INDUSTRY PROGRAM GUIDE - Amazon Web...
Transcript of INDUSTRY PROGRAM GUIDE - Amazon Web...
Patient Focused Certification
INDUSTRYPROGRAM GUIDE
1806 Vernon Street NW, Washington, D.C. 20009AmericansForSafeAccess.orgPhone: (202) 857-4272Fax: (202) 618-6977
A Project of Americans for Safe Access Foundation
AmericansForSafeAccess.org PatientFocusedCertification.org
Industry Program Guide
I. Introduction ............................................................................................................. 1
II. PFC Benefits and Services....................................................................................... 2
III. Developing and Adopting Industry Standards: AHPA and AHP ...................... 5
IV. Industry Trainings .................................................................................................... 7
V. Types of Certification Offered by PFC .................................................................. 9
VI. Certification Process ..............................................................................................12
VII. Ongoing Review and Compliance Process .........................................................15
VIII. Program Oversight.................................................................................................15
IX. PFC Auditor Qualifications ...................................................................................17
X. Fees and Discounts.................................................................................................16
XI. About ASA AHPA, and AHP ................................................................................ 17
XII. Frequently Asked Questions.................................................................................18
XIII. PFC Application` .....................................................................................................20
XIV. PFC Sample Audit Forms
1. Cultivation and Processing .............................................................................. 23
2. Manufacturing, Packaging, Labeling, and Holding..................................... 39
3. Laboratory Analysis .......................................................................................... 94
4. Distribution.......................................................................................................115
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Introduction
Welcome to the Patient Focused Certification (PFC) Program!
Americans for Safe Access Foundation (ASA) has created the Patient Focused Certification (PFC) Program toaddress issues of quality control and product safety in the cannabis industry to ensure patients (consumers) andtheir healthcare providers can rely on high-quality medical cannabis products and services. ASA has been advo-cating for safe and legal access to cannabis for therapeutic use and research on behalf patients for over adecade. Founded in 2002, ASA developed a vision for safe access that includes a legal and regulatory frame-work that has shaped the medical cannabis industry we see today.
The PFC Program has established guidelines that provide a system of processes, procedures, and documentationto ensure that Cannabis products (hemp, medical cannabis, and cannabis-derived products intended for humanconsumption) have the strength, composition, purity, and identity they claim to constitute or possess. PFC helpscompanies that are cultivating, manufacturing, and distributing these products achieve a commitment to quali-ty and product safety. PFC represents the consensus of the world’s leading experts on cannabis, hemp andbotanical product regulations.
The PFC program addresses quality control and product safety through:
1. Developing and Adopting Industry Standards
2. Industry Training
3. Certification Program
To date, we have:
��• Worked with American Herbal Pharmacopoeia (AHP) to release a Cannabis Monograph, which nowserves as a guide for identifying the quality, purity, and potency of the cannabis plant internationally;
�• Collaborated with the American Herbal Products Association (AHPA) to create the AHPA CannabisCommittee which has developed industry standards in the form of Recommendations for Regulators forDistribution, Cultivation, Analytics, and Manufacturing, Packaging and Labeling;
�• Worked with regulators to get AHP and AHPA cannabis standards adopted in over a dozen states and;
�• Partnered with American Chemical Society (ACS) divisions of Small Chemical Business(SCHB), Agricultureand Food (AGFD), and Chemical Health & Safety(CH&S) to create a Cannabis Chemistry committee toprovide education and training that addresses the needs of laboratories, chemists, and service/equipmentproviders
Our experienced staff have trained thousands in the medical cannabis industry over the last decade. The PFCtraining program prepares employees to understand state and local regulations and to meet required safetyand operational protocols, while teaching them the basics of cannabis as medicine and common therapeuticuses of cannabis. PFC training is currently licensed by the Department of Public Health in the District ofColumbia as a mandatory training for all staff working in the DC medical cannabis program.
PFC offers third-party certification and support services to companies cultivating, manufacturing, analyzing ordistributing medical cannabis products and is the nation’s only certification program based upon the AHPA andAHP standards. All PFC companies are required to adhere to these rigid quality standards. Certification includescompliance inspections, ongoing monitoring, regulatory updates, staff training and an independent complaintprocess for consumers.
PFC certified laboratories have each demonstrated that their equipment and instruments are calibrated andmaintained properly. Laboratories must also show that they have implemented operating protocols that arefollowed in accordance with the AHP Monograph and AHPA guidelines, establishing the first standardizedtesting of medical cannabis and medical cannabis products. Through standardized testing, patients and theirmedical practitioners can now have confidence that the products utilized not only comply with PFC’s highquality and safety standards, but are also properly labeled and standardized to ensure consistency of quality
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and effectiveness.
PFC certified companies are awarded the distinctive PFC mark to be displayed on promotional materials, prod-uct labeling and packaging to help distinguish products for consumers. PFC is similar to other nationally recog-nized certification programs including United States Pharmacopoeia (USP), Good Housekeeping, NSF, andInternational Organization for Standardization (ISO). PFC certification is currently offered as a voluntary certifi-cation program in all medical cannabis states for cultivators, manufacturers, dispensaries, and laboratories.
PFC Certification Highlights:
1. offers cannabis businesses a third-party auditing option that ensures compliance with standards requiredunder regulation and best practices;
2. provides your company visibility in all PFC advertising and marketing programs to patients, caregivers,and health care providers;
3. provides a mark that lets consumers, policy makers, regulators, health inspectors, community membersand health care providers know that companies are meeting compliance and product safety standardrequirements;
4. monitors violations of regulations;
5. provides trainings that include: Legal Issues, Robbery Preparedness, Patient Education, Good NeighborPolicies, Safe Handling Protocols, Working with Patient Populations, Understanding Test Results andDelivery Systems, Adherence to Local Laws and Regulations, and Adherence to AHPA and AHP standards;
6. provides companies with educational materials for patients, caregivers, healthcare providers and regula-tors that describe the certification program;
7. provides a third-party process to evaluate complaints, allowing you to identify, focus on and resolvelegitimate quality and service issues;
8. funds activities that benefit the medical cannabis industry, including education, legal services andresearch;
9. verifies through independent auditors that state and local rules, as well as AHPA and AHP standards, arefollowed by companies, ensuring patient safety and product quality, purity, and reliability;
10. offers third-party certification that can help reduce company liability and oversight burden;
11. provides companies and, if required, regulators with annual Audit Reporting;
12. assists your company with regulatory acceptance by verifying the reliability, consistency, and accuracy ofyour processes;
13. is overseen by a Peer Review Board that has over 300 years of collective expertise in USDA food andproduct safety protocols; federal regulatory development; medical cannabis research, pharmacology, bio-chemistry, and industry practices.
II. PFC Benefits and Services
BENEFITS
Government Relations: PFC works at the local and state level to increase awareness of the AHPA standards andthe AHP Cannabis Monograph with relevant agencies. PFC and AHPA work directly with legislators, regulatorsand industry trade groups to encourage the adoption of AHPA’s Recommenda-tions to Regulators and stan-dards outlined in the AHP Cannabis Monograph. As such, regulators in the states of Alaska, Florida, New York,Illinois, Maryland, Nevada, Washington, Oregon, Massachusetts, Minnesota, Hawaii, and Colorado have adopt-ed portions of the AHPA’s Recommenda-tions and/or the AHP Cannabis Monograph.
As the regulatory framework for medical cannabis businesses continues to develop throughout the US, demon-strating adherence to national best-practice standards can help businesses avoid being subjected to the devel-opment of onerous state and local regulations that may challenge the ability of small businesses to be
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successful. Throughout history, big business, with the support of government, has used unnecessarily narrow orstringent regulations to monopolize marketplaces. Certifying your business with PFC shows regulators and law-makers that your business has high standards of operation in accordance with other botanical products, dis-couraging the development of overly restrictive regulations.
Both ASA and AHPA are dedicated to the adoption of mandatory standards for the medical cannabis industrynationally. Your participation in the PFC Program helps to ensure that our outreach to your specific regulatorsgives your company an advantage.
Be prepared for regulatory inspections: In today’s regulated marketplace, failure to meet regulatory com-pliance can result in the denial of licensure for an applicant. Or, in the case of an established company canresult in costly fines, the recall and/or confiscation of products, and suspension or termination of your compa-ny’s license. As a participant in the PFC program, your company can rest assured that PFC’s inspection auditorswill identify any and all compliance issues that could jeopardize your company’s ability to maintain compliancewith local and state regulations. As localities and state regulators adjust and update regulations, PFC staff willensure that your company is aware of all upcoming regulatory changes.
Reduce company liability: Prior to the adoption of product safety guidelines in the herbal, botanical, andnutraceutical industries product liability lawsuits continually challenged the stability, growth, and future ofthese companies. As public concern in the US mounted over the increasing number of product liability lawsuitslarger agencies such as the FDA entered into the conversation about regulations and pressures rose to restrictherbal, botanical, and nutraceutical products from public availability. However, through the voluntary adop-tion of rigorous product safety guidelines, the herbal, botanical and nutraceutical industry was able to ease theconcerns of both the public and regulatory agencies allowing the industry to stabilize and avoid overly onerousFDA regulations.
Today, the medical cannabis and adult use industry find themselves in a very similar situation. As medicalcannabis and adult use laws have been implemented throughout the US, product safety has been an after-thought in many of these laws and rule making processes. By working with PFC to adopt nationally recognizedproduct safety standards, you directly reduce your company’s service and product liability. Through proper lotand batch number tracking, health and hygiene protocols, standardized testing, proper labeling, as well asadverse event reporting and recall strategies cannabis businesses who wear the PFC seal of approval raise thebar of product safety to that of the herbal, botanical, and nutraceutical industry in the US.
PFC certification helps your company identify, develop and address product safety protocols before a productsafety liability issue can arise. Engaging in the PFC program costs the average company less than 1% of theirannual revenue whereas product liability lawsuits often cost companies hundreds of thousands of dollars. LetPFC help your company develop a solid foundation of product safety and avoid costly product liability lawsuitsthat often irreparably damage businesses or close them all together.
Instill confidence in consumers and health care providers: The PFC seal displayed by cannabis businessesand on cannabis/hemp products provides medical practitioners, patients, and regulators with peace of mindthat your company is adhering to regulatory guidelines. The seal also shows that your company is committed tothe purity and identity of products being sold, has implemented lot and batch number tracking protocolsincluding an operations product recall plan, and has implemented standardized methods for the cultivation,manufacturing, distribution, and lab testing of those products.
Additionally our outreach programs educate patients, their caregivers, and medical professionals to look forPFC certified products so that they can choose their medicine with confidence, knowing that it was produced ina manner that provides consistent results and protects consumer safety. PFC’s advertising and marketing promi-nently features our certified companies and includes both traditional industry publications and unique chan-nels, such as Complementary and Alternative Medicine outlets.
Have confidence in company compliance: As medical cannabis, adult use, and hemp businesses haveemerged in the legal marketplace , state and local lawmakers have created a patchwork of laws and regula-tions. Almost all companies entering into the PFC program will find that some form of corrective action is nec-essary to achieve and maintain certification. Let PFC help your company achieve excellence in compliance, Best
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Business Practices, quality of care, and product safety.
Due to the ever-changing and expanding nature of medical cannabis regulations and medical cannabis industryinnovations, PFC recognizes the need to continually review and adopt new standards and guidelines thatreflect regulatory changes. For this reason the PFC Program has been developed as a continually evolving pro-gram overseen by a Peer Review Board which along with AHPA and AHP act to oversee the ongoing update ofPFC program standards. Depending on the extent of standard updates approved by the PFC Peer Review Board,a PFC auditor may be assigned to the affected certified companies in order to verify that all necessary compli-ance updates have taken place. Additional staff training may also be required. The addition of programrequirements, determination of corrective actions, and need for additional trainings, are all determined by thePFC Peer Review Board.
Complaint hotline, investigation and resolution: PFC operates an independent complaint hotline that pro-vides patients, consumers, and caregivers the means to report a concern, complaint, or adverse event relatingto a service or product. If a verified third-party complaint is recorded and it is determined to require an investi-gation or a large number of complaints are lodged against a specific certified service or product, a review auditmay be necessary. PFC will evaluate and respond to all third-party complaints verifying the legitimacy andseverity of the complaint, and when necessary, require immediate corrective action. Certified companies arerequired to respond to complaint inquiries within five (5) business days of notification by an assigned PFC audi-tor or staff person.
When filing a complaint, a Complaint Investigation Request provided by PFC and available online, must becompleted and signed by the complaining party. Complaints will be sent directly to the Program Director, whowill track all complaints and investigations. PFC will acknowledge receipt of the complaint, promptly investigateand validate the complaint, and take appropriate actions. PFC shall ensure the proper corrective actions havebeen implemented and notify the complainant of such actions. The certified company will be advised of thecomplaint at the appropriate time during the investigation. PFC shall determine, together with the certifiedcompany and complainant (and regulators where necessary), if the complaint and resolution should be madepublic.
When a complaint is made by a company, whether PFC certified or not, the complainant agrees to bear thecost of an investigation if the complaint is not verified. If the complaint is substantiated, the certified companyshall be responsible for all costs of the investigation. Regulatory authorities, individual consumers, and licensedhealth care providers are exempt from bearing the costs of any investigation costs. PFC shall not identify thecomplainant unless required to do so by law. If a complainant does not sign a Complaint Investigation Request,PFC will consider it an informal complaint and will investigate as needed but has no obligation to investigate orrespond.
Services: Patient Focused Certification offers a variety of services designed to calibrate your business for excel-lence regardless of whether your company is just entering into the marketplace or is already an establishedprovider.
PFC Advisory Services: Not sure if your company is ready to engage in the PFC program? Starting a newbusiness and need guidance on local and state compliance or Best Business Practices? Or, maybe you have anin-house production lab that doesn’t qualify for certification but your company could benefit from bringing itup to PFC standards? The Patient Focused Certification staff can help your company answer these questionsthrough the PFC Advisory Services Program. The PFC Advisory Program gives your company access to some ofthe industry’s best technical experts, delivering consistent, personalized service with the highest levels ofintegrity. To engage in PFC’s Advisory Services, simply fill out an application and check the Advisory Servicebox. Within 5 business days a PFC staff person will contact your company to discuss the breadth of servicesdesired and assign the appropriate staff and/or auditor(s) to assist your company. All PFC Advisory Services arebilled at a rate of $150 per hour plus travel expenses.
Pre-licensing Certification: Companies interested in the PFC program but not yet licensed can engage in thePFC program and begin the audit process prior to license approval by providing PFC with a 50% deposit. In thiscase, the company must be able to show verification that all staff, as identified on the application, have success-fully completed the PFC Core Cannabis Training and that the company has successfully completed a document
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audit of all proposed SOP’s and Employee Manuals by an assigned PFC auditor. As with other document auditsconducted for PFC, the assigned PFC auditor will create a detailed audit report for the company outlining anycorrective actions necessary for the SOP’s to meet the standards of the PFC program as well as local and stateregulatory requirements. All corrective actions must be successfully implemented prior to receiving PFCapproval from the assigned auditor. PFC will then provide the company with a letter of engagement verifyingthat the provided documents are of adequate content to show that the company has implementable proce-dures ensuring compliance with local and state laws, and applicable PFC standards. Upon approval of statelicensure, your company is encouraged to complete the PFC required trainings. All companies engaged in pre-licensing certification are required to complete the certification process within 90 days of opening the companyfor operation.
Industry Certification: Medical cannabis, adult use cannabis and hemp product companies operating withinthe legal parameters of local and state regulations are encouraged to apply for the PFC certification . OncePFC has received the required 50% deposit, PFC staff will assign an independent auditor to your company andschedule the document and physical audits. PFC staff will also request a full employee list from your companyand assist your company in enrolling in the required PFC training courses. Upon the successful completion ofthe pre-certification audit process, subsequent corrective actions, and required staff trainings PFC staff willissue your company an official certification packet, including directions for the proper branding and use ofthe PFC seal.
Industry Training: PFC’s required staff training program is designed to meet the requirements of statemandated training programs, provide your staff with continuing educational opportunities, and can helpyour company reduce the cost of developing, implementing and operating in-house medical cannabis train-ing programs.
III. Developing and Adopting Industry Standards: AHPA and AHP
Seed to consumption national quality standards now exist for the medical cannabis industry thanks to the 2011collaboration of ASA, the American Herbal Products Association (AHPA), and the American HerbalPharmacopoeia (AHP). This unique collaboration combines the expertise of ASA, the nation’s largest medicalcannabis patient advocacy organization; AHPA, the principal U.S. trade association and voice of the herbalproducts industry since 1982; and the AHP, an organization that has developed qualitative and therapeuticmonographs on Western herbs since 1994. The result is that patients, healthcare providers, lawmakers, regula-tors, and medical cannabis businesses now have the tools they need to ensure reliable, high-quality hemp,medical cannabis, and medical cannabis products.
Founded in 1982, AHPA is the oldest non-profit organization specializing inservice to the herbal industry. All of AHPA’s activities are focused on its mis-sion, to promote the responsible commerce of herbal products. These activi-ties are undertaken to maintain and improve market opportunities for
companies that sell herbs, herbal and botanical products, and other health-related products, including foods,beverages, dietary supplements, and personal care products, while also ensuring that consumers continue toenjoy informed access to a wide choice of goods. In 2010 AHPA established a Cannabis Committee tasked withthe development of national Recommendations to Regulators that address sensible regulatory practices forhemp, cannabis, and cannabis-derived products. As such, the AHPA’s Cannabis Committee developed a series ofRecommendations to Regulators, or guidelines, in the following four areas:
1. Cultivation and Processing—Intended to establish a basis for oversight of entities that cultivate cannabisin outdoor, greenhouse, and/or indoor facilities, these guidelines address good cultivation practices,pesticide guidance, facility requirements, management of water resources, recordkeeping, product safetyrecall systems, adverse event recording, and information disclosure. These recommendations alsoestablish best practices and safe handling procedures for operations that provide post-harvest processingof cannabis.
2. Manufacturing, Packaging, Labeling and Holding—Intended to establish a basis for oversight of entitiesthat are engaged in the manufacturing of cannabis and cannabis-derived products, these guidelines are
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modeled after federally recognized Good Manufacturing Practices (GMPs) for botanical andnutraceutical products. These recommendations ensure that GMP’s are maintained in manufacturingoperations by focusing on personnel, physical condition of the plant and surrounding grounds,manufacturing controls, packaging, holding, and labeling controls, cannabis material acquisition,inventory and recordkeeping, complaints, returns, product safety recalls, and adverse event recording.
3. Distribution—Intended to establish a basis for oversight of entities that provide cannabis and cannabis-derived products directly to compliant individuals through storefront operations, delivery services, direct-from-garden operations, and growing co-op operations, these guidelines focus on personnel, security,product acquisition, record keeping, customer policies, implementable product safety recall systems,adverse event recording, and other matters that can contribute to best practices in the dispensarysetting.
4. Laboratory Analysis—Intended to establish a basis for the oversight of entities performing laboratoryanalysis of cannabis, cannabis-derived products, and hemp products, these guidelines were developed asa complement to existing good laboratory practices and focus on the personnel, security, samplehandling and disposal, data management, personnel safety and hygiene, and reporting activities thatmay be unique to laboratories analyzing cannabis, cannabis-derived products, and hemp samples. Inaddition to the AHPA guidelines, PFC certified laboratories are also required to adhere to the standardspresented in the AHP Cannabis Monograph.
Established in 1995, the American Herbal Pharmacopoeia (AHP) is a non-profit501(c)(3) California- based organization with a mission to promote the respon-sible use of herbal products and herbal medicines. The AHP produces criticallyreviewed documents called monographs that outline the quality control criteria
needed for ensuring the identity, purity, and quality of botanical raw materials.
Each monograph also presents a complete and critical review of the traditional and scientific literature regard-ing the efficacy and safety of herbal medicines and includes information on specific products such as tincturesand extracts. In 2011, the AHP began the development of a Cannabis Monograph and a TherapeuticCompendium for Cannabis. The first edition of the Cannabis Monograph was released in 2013 and provides sci-entifically valid standards for companies engaged in laboratory analysis of cannabis, cannabis-derived products
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and hemp products with regards to:
1. Ensuring the identity, quality, purity, and potency of cannabis, cannabis-derived and hemp products;
2. Reporting, analytic equipment calibration and method validation;
3. And, ensuring product safety by identifying safe levels of pesticides, metals, and microbial limits.
PFC works at the local and state level to increase awareness and adoption of the AHPA guidelines and the AHPCannabis Monograph with relevant agencies. PFC and AHPA also works directly with regulators and industrytrade groups to coordinate the further development of cannabis industry standards. ASA is dedicated to theadoption of mandatory standards for the cannabis industry nationally. Quality control and product safety stan-dards based on the AHPA guidlines and the AHP Cannabis Monograph have been adopted in over a dozenstates.
IV. Industry Training
As state medical cannabis laws and regulations continue to evolve, medical cannabis-specific trainings havebecome increasingly mandated. States such as Arizona, Massachusetts, Nevada, Florida, Illinois, Connecticut,Washington, Maryland, Oregon, and the District of Columbia have mandated comprehensive training for allstaff working or volunteering in state-licensed medical cannabis facilities. PFC’s required staff training programis designed to meet the requirements of state mandated training programs and can help your company reducethe cost of developing, implementing and operating in-house medical cannabis training programs.
PFC currently holds the first government-issued educational permit from the District of Columbia to provide therequired staff trainings for the District’s legal medical cannabis providers. Additionally, PFC has been awarded acontract with the State of Maryland to train all compliance inspectors for the State’s medical cannabis program.
As a leader in medical cannabis education since 2002, ASA has distributed millions of copies of educational litera-ture to patients, healthcare professionals, researchers, industry labor, regulators, and concerned communitymembers and has conducted thousands of legal and advocacy trainings nationwide.
The PFC required trainings include the Core Cannabis Training, the National Cannabis Standards training(s) anda State Specific Legal and Compliance training. PFC is constantly developing new course material designed tofulfill the requirements of state mandated trainings, while providing ongoing educational opportunities toenrich and meet the continuing educational needs of your company’s staff. PFC trainings are available onlineor are offered in-person by a PFC Certified Instructor.
1. CORE CANNABIS TRAINING (CCT)
This training provides the foundation for PFC required trainings and is a prerequisite for all additional training.All paid and volunteer staff, working at a PFC company, are required to successfully complete the CCT. The CCTcourses address the following topics:
�• CANNABIS RESEARCH AND CLINICAL DATA: Find out what research is revealing about the therapeuticpotential of cannabis, and learn what types of pain, disorders and diseases this plant potentially relieves.Clinical trials and their importance are also covered. Finally, see what groundwork has been laid forfuture cannabis research.
�• THE ENDOCANNABINOID SYSTEM: This module gives a brief history of opioids and cannabinoids, andexplains how the endocannabinoid system was discovered. The workings of the endocannabinoidsystem. This module will also explore the physiological role of endocannabinoids.
�• CANNABIS 101: Gain a fundamental understanding of the cannabis plant by learning the varieties ofcannabis and their uses, the most common cannabinoids, the effects of cannabis, and the differencebetween psychoactive and non-psychoactive cannabinoids.
�• CANNABIS-BASED MEDICINES: Cannabis-Based Medicines covers the cannabis pharmaceuticals that are
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currently available. It also takes a look at cannabis extracts and concentrates and how they might beused. The module concludes with a section on cannabis edibles including a brief discussion about howcannabis might be incorporated into topicals, food and drink.
��• QUALITY OF CARE: Targeted at dispensary workers, this module covers customer service, how to identifyand handle medical emergencies, and patient education. A discussion of the Patient’s Bill of Rightsfinishes the module.
�• KNOW YOUR RIGHTS: This module prepares you for interactions with federal law enforcement (FLE).Know what to do in event of detainment or arrest as well as how to answer questions from FLE. Finally,understand when Miranda warnings apply.
�• ROBBERY PREPAREDNESS: Cannabis businesses, like other businesses, are at risk for being robbed .Know what to do should this happen. In this module, learn what operations should be followed duringa robbery to keep employees safe . Discover what logistical and security preparations should be taken inadvance to decrease the chances of a robbery and what protocols should be in place for staff andcustomers should they bep resent during a robbery.
�• RUNNING A SAFE BUSINESS: Dispensaries, cultivators, and processing centers alike need to takeprecautions to ensure the safety of their product. Learn how to spot contaminants and maintain safeand sanitary conditions. Security considerations will also be discussed. The module concludes with tips onneighborhood and community relations.
2. NATIONAL STANDARDS COURSES
The National Cannabis Standards Training(s) are designed to educate attendees about the particulars of compli-ance specific to the AHPA and AHP guidelines. National Cannabis Standards Trainings are available in fourcannabis industry disciplines. All paid and volunteer staff working at PFC companies are required to successful-ly complete the National Standards Course work in the discipline(s) that the staff person will be working in. Forexample, all staff working in cultivation and/or processing facilities must successfully complete the NationalStandards Course in Cultivation and Processing.
A. CULTIVATION AND PROCESSING: Based on the AHPA Recommendations to Regulators for Cultivationand Processing operations, this training applies to all types of cultivation operations including outdoor,greenhouse, and indoor cultivation facilities. This training is designed to provide learners with the skillsnecessary to implement Good Cultivation Practices including pesticide guidance, facility requirements,water resource management, recordkeeping, product safety recall systems, adverse event reporting, andinformation disclosure. This course also explores best practices and safe handling procedures foroperations that provide post-harvest processing of cannabis.
B. MANUFACTURING, PACKAGING, LABELING AND HOLDING: Designed for individuals engaged in themanufacturing of hemp and cannabis-derived products, this training is designed to provide learners withthe tools necessary to comply with General Manufacturing Practices including general personnelresponsibility and safety, physical condition of the plant and surrounding grounds, manufacturingcontrols including packaging, holding and labeling controls, cannabis material acquisition, inventory andrecordkeeping, fielding and documenting complaint,product returns, product safety recalls, and adverseevent reporting.
C. DISTRIBUTION: This comprehensive training is designed to provide participants with the skills necessaryto implement Best Management Practices relating to the distribution of cannabis, cannabis-derivedproducts, and hemp-derived products directly to compliant individuals through storefront operations,delivery services, direct-from-garden operations, and growing co-op operations. This training includesinformation regarding personnel policies, facility security, product acquisition, record keeping, customerpolicies, implementable product safety recall systems, and adverse event reporting.
D. LABORATORY: Designed for individuals performing laboratory analysis of cannabis, cannabis-derivedproducts, and hemp products, this course has been developed to educate learners on good laboratorypractices and focuses on facility security, sample handling and disposal, data management, personnelsafety and hygiene, and reporting activities that may be unique to laboratories analyzing cannabis,cannabis- derived products, and hemp product samples.
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3. STATE SPECIFIC COMPLIANCE TRAINING
Each State-Specific Compliance Training is designed to give medical cannabis staff a comprehensive foundationof knowledge, ensuring they know the compliance expectations of local and State government and regulatoryagencies.
� �• STATE AND LOCAL LAWS: Medical cannabis facilities are often regulated by both State and local laws.During this training, participants will get to know their local and state medical cannabis laws and howthose laws apply to them as medical cannabis facility staff, as well as to the patients they will be serving.
� �• STATE AND LOCAL REGULATIONS: This training provides a broad regulatory overview, necessary tomaintain compliance, in all disciplines of the medical cannabis industry. Because compliance may besubject to both State and local oversight, this training discusses the specifics of both local and Stateregulatory provisions.
ADDITIONAL STATE REQUIREMENTS
As medical cannabis laws continue to evolve, additional trainings above and beyond the PFC required trainingsare sometimes required by law. For this reason, PFC offers a broad array of “enrichment courses” designed toassist medical cannabis businesses in fulfilling all mandatory training requirements. Additionally, whererequired by law, these trainings will cover the specific aspects of the State and local requirements unique to theoperation of that State’smedical cannabis program. These trainings may also be utilized to meet the continuingeducation requirements of PFC companies engaging in recertification and include, but are not limited to, thefollowing PFC course options.
� �• PESTICIDE GUIDANCE AND INTEGRATED PEST MANAGEMENT (IPM): This in-person course isrecommended for all staff who will be working in cultivation and processing facilities. During thiscourse, students are familiarized with key definitions pertaining to pesticides and learn how to properlyread a pesticide label. The course will also explore the importance and function of tolerance thresholds,major chemical families, Restricted Entry Intervals (REI’s), and Personal Protective Equipment (PPE’s) aswell as employee safety and employer responsibilities. The second portion of this course covers the keycomponents to successful IPM.
� �• SUSTAINABILITY, SANITATION, AND RECORD KEEPING FOR CULTIVATION FACILITIES: This course isrecommended for all PFC company staff engaged in cultivation and processing operations . Designed tohelp cultivators reduce their impact on the environment, this course provides tools for reducing thecarbon footprint of cultivation operations as well as the use, recycling and reuse of mediums. In addition,this course discusses appropriate nutrient use, the consequences of mined and imported materials, andthe proper storage of chemicals. Water resource use, storage, and reduction techniques are alsoaddressed in this course as well as the proper tracking of materials used during the cultivation process.
� �• REPRESENTATIVE BATCH and LOT SAMPLING - QA/QC: This course is recommended for of all PFC staffregardless of the discipline(s) they will be employed for. During this course, learners will be providedwith an overview of paradigm shifts and global perspective relating to Quality Assurance (QA) andQuality Control (QC). Details on developing and implementing QA/QC systems will be discussedincluding method validation and General Manufacturing Practices (GMP’s) as they relate to QA/QCtopics.
(PFC reserves the ability to require additional training, as recommended by the PFC Peer Review Board, toensure compliance with any changes to the AHPA and AHP guidelines, local and state regulatory updates, andduring certification renewal.)
V. Types of Certification Offered
Patient Focused Certification is available to cannabis companies in all states with medical cannabis and/or legaladult use laws in place and is designed to show the quality commitment of cannabis companies engaged inproviding patients with hemp, cannabis, and cannabis-derived products. There are several options for certifica-
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tion available to companies engaged in the PFC program ranging from single discipline certification to multiplediscipline certification options. While all available PFC program certifications verify compliance with local andstate laws and regulations, as well as AHPA and AHP guidelines, some areas of certification may require addi-tional trainings and/or additional compliance criteria, such as for companies engaged in manufacturing or labo-ratory testing operations.
CULTIVATION CERTIFICATION
��• Ensures the company is compliant with state and local regulations, includinglicensing, zoning, and environmental requirements.
� �• Demonstrates the safety of products used in the cultivation process.
� �• Verifies that the raw medical cannabis does not contain an unacceptable levelof contaminants.
� �• Verifies adherence to AHPA and AHP quality standards and that procedures arein place for implementable product recall protocols, adverse event reporting,proper storage, and safe handling protocols.
� �• Determines the hazard, risk, and impact of the products used during the cultivation of medical cannabis,protecting the health and well being of the environment, employees, and patients.
� �• The Cultivation Certification process includes: comprehensive staff training, a document review, a labelreview to verify product and marketing claims, a thorough facility inspection, and laboratory testing anda contaminant review to ensure there are no unsafe levels of contaminants.
MANUFACTURING, PACKAGING, LABELING AND HOLDING CERTIFICATION
• Ensures the company is compliant with state and local regulations, licensing,zoning, and applicable environmental requirements.
� • Verifies the identity, purity, quality, and quantity of ingredients declared on theproduct label.
� • Demonstrates the product does not contain undeclared ingredients.
� • Verifies that the product does not contain an unacceptable level ofcontaminants.
� • Verifies adherence to AHPA and AHP quality standards and procedures, including product recallprotocols, adverse event recording, as well as proper packaging, labeling, storage, and handling systems.
� • Determines the hazard, risk, and impact of the products used in the medical cannabis manufacturingprocesses to ensure environmental, employee, and patient safety.
The Manufacturing, Packaging, Labeling, and Holding certification process includes: comprehensive staff train-ing; document review; a label review to verify product identity, formulation, and marketing claims; a formula-tion review to identify and quantify dietary ingredients declared on the product label; a contaminant reviewand laboratory testing to ensure there are no unsafe levels of contaminants; and a thorough facility inspection.
DISTRIBUTION CERTIFICATION
� • Ensures the company is compliant with state and local regulations, licensing,and zoning requirements.
� • Verifies adherence to AHPA and AHP quality standards and procedures,including product recall protocols, adverse event reporting , and properstorage and handling systems
� • Determines the hazard, risk, and impact of the processes used in themedical cannabis distribution operation to ensure community, employee,and patient safety.
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The Distribution certification process includes: comprehensive staff training, document review, a label review toverify product formulation and marketing claims, and laboratory testing to ensure there are no unsafe levels ofcontaminants in products provided to patients.
LABORATORY CERTIFICATION
� • Ensures the company is compliant with state and local regulations,environmental, licensing, and zoning requirements.
� • Demonstrates the laboratory’s commitment to accuracy and integrity.
� • Verifies adherence to AHPA and AHP quality standards and procedures,including proper calibration, storage, and handling systems.
� • Determines the hazard, risk, and impact of the processes used in the medicalcannabis laboratory to ensure employee and patient safety.
The Laboratory Testing certification process includes: comprehensive staff training,document review, equipment and standards review, testing verification, and a thorough facility inspection.
MULTIPLE DISCIPLINE CERTIFICATION
For those companies engaged in multiple types of industry operations, PFC offersmultiple discipline certifications. This certification opportunity allows companiesengaged in a combination of cultivation, manufacturing, and/or distribution to certifyall areas with one PFC seal of approval denoting the combination of disciplines and acommitment to product safety for all aspects of their operation. In order to upholdthe integrity of PFC independent laboratory testing services and the product safetyverification such certified laboratory’s offer, PFC does NOT allow laboratory certifica-tion to be combined with other disciplined operations receiving PFC certification. If aPFC laboratory operation wishes to certify in a second discipline, then the certifiedlaboratory facility may NOT be used to satisfy the testing requirements of the second-ary discipline.
VI. Certification Process
HOW TO BECOME CERTIFIED
PFC offers a confidential and supportive certification process that includes:
1. Application—the PFC process begins when the licensee or licensee applicant provides a completedapplication to PFC. A confidential review of the business operations is completed to determineappropriate inspections and testing.
2. Quote—using information generated by the Application, PFC staff prepares a price quote and anestimate of time required for completing the certification process
3. Contract—a contract is executed outlining the responsibilities of all parties involved including financialobligations, non-disclosure protections for the applying company, and acceptance of terms.
4. Preliminary Assessment (optional)—available as PFC Advisory Services, PFC staff is available to provideprocedures for an upcoming document and physical audit and can work with management to preparethe operations facilities and processes.
5. Documentation Audit—an offsite review of company documentation determines if the company’slicensing and processes are sufficient to ensure adherence to standards.
6. Training Audit—verification of the mandatory training of all paid and volunteer employees, including allnew hires that occur over the course of the certification year. This audit is ongoing and employees musthave successfully completed all PFC required trainings prior to certification approval or renewal.
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7. Document and Facility Audit—trained independent PFC field inspectors conduct a confidential PFCstandards audit and a facility inspection.
8. Product Testing— PFC tests for pesticides, molds, and contaminants with an independent third-partylaboratory when available, necessary, and appropriate for certification or complaint resolution.
9. Initial Scoring and Corrective Recommendations—the licensee receives the results of the PFC audit and isgiven corrective actions to be remedied as needed.
10. Secondary Audit—as needed
11. Certification—the PFC Review Board will issue the licensee’s certification once the PFC auditor verifiesany required corrective actions have been remedied and all compliance standards have been met.
HOW TO PREPARE FOR CERTIFICATION
Your company is ready for certification after you’ve implemented good management practices based on AHPAstandards, trained employees to become proficient with processes, and developed a sufficient evidentiary trailof documents that can be assessed. PFC staff can provide applicants with discounted training programs, as wellas document preparation and advisory services to help you company prepare for certification. Please contactPFC for additional information on advisory services.
PRELIMINARY ASSESSMENT
In many cases, the company seeking certification may request an optional preliminary assessment of their oper-ations which is offered through PFC’s Advisory Services. This gives PFC the opportunity to identify in advanceany weaknesses that may exist in the company’s management systems. A preliminary assessment gives the com-pany sufficient lead- time to correct deficiencies before audits are conducted and assists PFC in planning for thecertification. The scope of the preliminary assessment is determined by the company and may range from areview of documents to a full assessment, including on-site operational observation and assessment. While thepreliminary assessment is optional, it is recommended. Ultimately, it may save time and expense by revealingdeficiencies that, if corrected before the required audits, can save the expense of follow-up audits before certi-fication can be granted.
DOCUMENTATION AUDIT
A PFC Independent Auditor assigned to the company will retrieve all local and state licensing documents, aswell as management system documents and manuals. The assigned PFC auditor will review the documentationto determine whether it meets all requirements of local and state regulations, and the AHPA and AHP stan-dards.
Documentation should include, at a minimum:
1. Standards manual(s) – outlining systems utilized to ensure compliance with state and local law andregulations as well as the AHPA and AHP guidelines
2. Operating procedures – including detailed descriptions on how to perform system functions;
3. Work instructions – defining specific job activities affecting the safety and quality of products andprocesses; and
4. Quality documentation – documents that demonstrate how quality is managed including records, charts,files, inspection and testing records, assessment results, implementable product recall procedures,adverse event reporting, and any other records of objective evidence.
If the documentation fails to meet standards, the deficiencies will be identified in an audit report, and the licenseeis required to take corrective action before certification can be awarded. Once PFC has determined that the docu-mented management systems are satisfactory, a facility audit will be scheduled.
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TRAINING AUDIT
A PFC auditor assigned to the company will verify that all paid and volunteer staff has successfully completedthe required PFC trainings. Successful completion of PFC required courses is documented by passing the corre-sponding on-line tests with a score of no less than 80%. All company staff must successfully complete therequired trainings prior to receiving certification and all new hires are required to successfully complete therequired trainings within 30 days of hire date in order for the company to maintain PFC approved company sta-tus.
FACILITY AUDIT
The assigned PFC auditor(s) will complete a thorough on-site assessment of the facility and its operations. Anaudit agenda will be prepared for the licensee prior to the arrival of the PFC auditor(s) including a daily sched-ule and any accommodation requests. It is the auditor(s) responsibility to verify whether the management sys-tems of the company meet all of the requirements of applicable standards.
Upon arrival at the facility, the PFC auditor(s) will conduct an introductory meeting followed by a full facilitywalk-through to observe activities and confirm that the operating procedures outlines in the document audithave been successfully implemented. All PFC auditors reserve the right to obtain samples for the purpose oflaboratory testing, conduct private interviews with employees, inspect documents and records, observe workprocesses, and examine equipment. The objective of the facility audit is to verify technical competency includ-ing statements, documented procedures, records, and written policies.
If deficiencies are found during the course of the audit, the PFC auditor(s) will bring the deficiencies to thelicensee’s attention and record them in the audit report as required or suggested corrective actions, dependingon the severity of the deficiency. The audit report will specifically describe, in detail, what deficiency wasobserved, the related standard or policy to which it relates, and the necessary corrective actions required toremedy the deficiency. PFC audit reports also include a recommended timeline for the company to receive certi-fication. This timeline varies depending on potential corrective actions.
PRODUCT TESTING
PFC provides a wide range of comprehensive medical cannabis product safety testing, where available (servicesmay be limited in some states). PFC’s independent laboratory testing services assist certified companies with theestablishment of product stewardship by confirming content and purity, identifying problems with contamina-tion, and determining potential for human and environmental exposure risk to ingredients and by-productsincluding potential allergens, residuals, and microbiological adulterants. The PFC program specializes in examin-ing product composition, proper packaging, labeling, and storage protocols that ensure public and patientsafety. PFC laboratory testing conducted for certification verification is provided by PFC independent certifiedlabs conforming to AHPA and AHP guidelines, as well as all applicable local and state laws and regulations.Laboratory testing for the purposes of certification verification is limited to necessary testing to meet standards.Where allowed by state law, our independent certified laboratory testing facilities can also provide patients,caregivers, and licensees cannabis analytical services as requested.
EXIT MEETING
Upon completion of the on-site audit, the assigned PFC auditor(s) will conduct an exit meeting. A summaryreview of the facility audit will be discussed with management or the primary contact person, and regulatorsas applicable. If deficiencies were recorded, they will be described at this time and included in the final facilityaudit report. All PFC applicants will be given a reasonable time period to implement any required correctiveaction(s).
CORRECTIVE ACTION
All companies with identified deficiencies will be given a reasonable timeframe to implement the mandated cor-rective action. PFC requires that all corrective actions be implemented and approved by the assigned auditorbefore certification can be granted. The corrective action response must include objective evidence, which shows
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the necessary corrective actions have been completed. PFC may require a follow-up on-site facility audit, limitedto the area of concern, depending on the nature of the deficiency. Certification cannot be awarded until anyand all deficiencies have been adequately corrected.
FINAL REVIEW, REPORT AND APPEAL PROCESS
Within 10 business days of the facility audit (if no deficiencies are found) or upon confirmation of completedcorrective actions, PFC will issue a confidential report and certification decision (report will be provided to regu-lators if necessary). All documentation will be forwarded to PFC’s Peer Review Board, and the ExecutiveCommittee will review the audit report and checklist prior to issuing a decision on the certification. If the PeerReview Board grants a company certification, they are notified immediately and the appropriate certificationmaterials will be issued.
In the event that an application for PFC certification is denied, an appeal may be submitted within 10 businessdays of the issuance of the decision. PFC provides an independent Dispute Board that includes at least threemembers from the PFC Peer Review Board. Each Dispute Board member must have sufficient knowledge andexpertise in the discipline to perform a review of materials and reports and issue an impartial decision.
CERTIFICATION
Upon the successful completion of PFC required trainings, audits, and necessary corrective actions the companywill become PFC approved and will receive a PFC approved materials package. PFC certification materialsinclude:
1. A certificate bearing the certified company’s name, physical address and the PFC’s certification logo;
2. PFC certification window decals;
3. Educational and promotional materials for patients, healthcare providers and regulators;
4. PFC website links;
5. A Standards Packet including applicable AHPA guidelines and an AHP Cannabis Monograph;
6. Verification that copies of the approved certification(s) have been sent to regulators and localities, asrequired by law;
7. Annual audit reports, audit checklists and compliance updates.
Once certification has been granted, the review period begins, and the company may be subject to randomand unannounced audits and/or product testing. An annual re-certification process is mandatory. Follow-upaudits may require document submissions and/or an on-site visit. Certified companies are required to respondwithin five (5) business days to any complaint submitted to PFC (by consumers, healthcare providers, stakehold-er groups, regulators, etc.) for which a response is determined by the PFC Peer Review Board, to be necessary.PFC will maintain records of complaints on certified companies. Such complaints may trigger unannouncedinspections depending on the complaint severity and/or frequency. If for whatever reason certification must besuspended, PFC will notify regulators.
CERTIFICATION PROCESS TIMELINE
The length of time required to complete the certification process depends on several variables including: thediscipline(s) and size of facility, number of employees, and complexity of operations. The amount of time ittakes a company to achieve readiness for certification depends on the quality of management systems currentlyin place. PFC provides optional advisory services to identify and resolve documentation and process deficienciesin advance of the audit process.
The speed of the certification process is dependent upon timely and complete responses from the applicant. Atypical certification process will follow a timeline similar to the following:
1. Application Submitted
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2. Quote Issuance3. Contract Execution 4. Preliminary Assessment Completion (optional)5. Documentation Audit – (3-5 business days)6. Facility Audit/Product Testing (3-5 business days)7. Corrective Action Period (if necessary) – (5-15 business days) 8. Final Review, Report and Decision – (5-10 business days)
VII. Ongoing Review & Compliance
The assigned PFC auditor and PFC staff will continually monitor certified operations throughout the annual cer-tification period. PFC is committed to working with companies engaged in the PFC Program to achieve excel-lence by providing ongoing support and monitoring of corrective actions.
In the event of a law or regulation change, or when AHPA or AHP releases updated standards, a review auditmay need to be completed. PFC staff will notify certified companies of any updates to rules, regulations, and/orstandards and provide an explanation of actions required by the company to comply with said update, includ-ing a required timeframe for compliance.
VIII. PFC Program Oversight
The PFC Program is overseen by the PFC Peer Review Board that provides over 300 years of collective expertisein the realms of USDA food and product safety protocols, federal regulatory development, medical cannabisresearch, medical cannabis industry operations, pharmacology, and biochemistry. The PFC Peer Review Board istasked with the annual review and update of audit methodologies and program standards, the processing andreview of all certification appeals, complaint investigation and resolution, and any and all revocation actions.The review board may be asked to weigh in on a company’s corrective actions as determined through either ascheduled or a secondary follow up audit. Expanded PFC Peer Review Board bios can be found at patientfo-cusedcertification.org.
PFC REVIEW BOARD
Dr. Sunil Aggarwal, M.D., Ph.D., is an Associate Member of the New York Academy of Medicineand a Resident in Physical Medicine and Rehabilitation at NYU’s Rusk Institute of RehabilitationMedicine. As a NYU Graduate Research Fellow, he conducted human studies of medical cannabisuse under the first federal Certificates of Confidentiality ever granted.
Todd Dalotto is a cannabis industry consultant, horticultural scientist, public policy advisor, andexpert witness specializing in medical cannabis. Todd is the Chair of the Oregon Health Authority’sAdvisory Committee on Medical Marijuana, chairs the ACMM’s Horticulture, Research & SafetyCommittee, and helped draft the regulations for Oregon’s licensed dispensary law.
Don Duncan has served on the Board of Directors of Americans for Safe Access since he co-found-ed it in 2002. As California Director, he is coordinating the grassroots and grasstops campaign tofully implement the state’s medical marijuana laws, respond to federal interference, and build abroader, more powerful coalition for medical marijuana. Don co-founded one of the oldest andmost reputable families of medical cannabis dispensing collectives in California, helping to open
legal facilities in Berkeley, West Hollywood, and Los Angeles.
Dr. Robert L. Epstein served as Associate Administrator and Chief Operating Officer for theAgricultural Marketing Service, U.S. Department of Agriculture (USDA) from January 2013 until hisretirement in June 2013. With over 34 years of service at the USDA Dr. Epstein has held variousleadership positions involving food safety, laboratory services, toxicology, residue chemistry, andquality assurance.
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Jill Lamoureux has a background in toll road operation and municipal bond finance, and anMBA from the University of Denver. She is a founding member of, and served as the first womanChair of the National Cannabis Industry Association and has been a leader in Colorado’s medicalmarijuana industry since. Jill developed Patient Focused Certification with Americans for SafeAccess and serves as Chair of the PFC Peer Review Board.
Philippe G. Lucas holds a master’s degree in the area of Studies in Policy and Practice from theUniversity of Victoria and is co-owner and COO of the Canadian Cannabis Research Institute.Philippe has also served as a co-investigator for Medical Cannabis Standards, Engagement,Evaluation, and Dissemination (SEED) Project, and served on the Victoria City Council from Nov2008-Nov 2011.
Jahan Marcu, Ph.D. is the Vice-Chair of the Americans for Safe Access Multidisciplinary ScientificAdvisory Board and is currently investigating the pharmacology of cannabinoid receptors atTemple University. He received his Ph.D. for studying the structure and function of the CB1 recep-tor, and the role of the endocannabinoid system in bone.
Michael McGuffin is President of the AHPA and Managing Editor of AHPA’s Botanical SafetyHandbook, and of Herbs of Commerce, second edition (2000). He serves on the boards of the AHPand United Plant Savers, and on the Advisory Board of the USC School of Pharmacy RegulatoryScience Master’s Degree Program.
Kristin Nevedal is Director of PFC and chairs the AHPA Cannabis Committee’s Cultivation WorkingGroup, assisting in the development of model cultivation regulations and best practices for agencyconsideration. She is also an instructor at Oaksterdam University, teaching classes on environmentalsustainability and Best Management Practices, as well as Co-Founder and Chair of the EmeraldGrowers Association.
Dr. Michelle Sexton is a naturopathic doctor, herbalist, educator and clinical cannabis researcher.Dr. Sexton completed a postdoctoral fellowship focused on the endogenous cannabinoid signalingsystem (ECS) in the Departments of Pharmacology and Psychiatry and Behavioral Medicine at theUniversity of Washington. Michelle is also research faculty at Bastyr University research instituteand Technical Advisor to the American Herbal Pharmacopoeia.
Steph Sherer is a medical marijuana patient with over 15 years managing non-profit businessesand community organizations including: event planning, consulting, fund development, publicrelations, and project management. Steph is a powerful advocate, a skilled spokesperson, an ener-getic initiator of campaigns, and a nationally recognized activist in the global justice movementand a guest lecturer at the University of California, Berkeley and George Washington University,DC.
Tim Smale is the Co-Founder and Executive Director of Remedy Compassion Center in Auburn,Maine and a results-driven leader with over 30 years domestic and international experience withnonprofit and for profit organizations, from small businesses to Fortune 100 companies.
E� lan M. Sudberg, CEO of Alkemist Labs, holds a degree in chemistry and has authored numerousjournal articles on phytochemistry. He is the instructor of AHPA’s Seminar on MicroscopicIdentification of Popular Botanical Materials, an appointed board of trustees member of AHPA, aboard member of AHPA’s ERB Foundation, and the former Chair of the Hemp and MedicalMarijuana Committee. He serves as a Technical Adviser for the AHP.
Dr. Jim Tozzi worked for five consecutive presidential administrations, including service as the sen-ior career regulatory policy official at the White House Office of Management and Budget. Dr.Tozzi is the father of the Data Quality Act and has been appointed to the AdministrativeConference of the US overseeing the federal regulatory process.
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IX. PFC Auditor Qualifications
PFC independent auditors have extensive experience in the medical cannabis industry or in auditing similarindustry and/or the herbal products industries. All PFC independent auditors are required to successfully com-plete the PFC trainings and are assigned a mentor to oversee PFC audits until such time as the mentoring audi-tor can verify the trainees’ readiness to audit without mentor oversight. All auditor trainees are required toconduct a minimum of two audits per discipline with his or her mentor before being allowed to audit inde-pendently.
All PFC Cultivation and Processing auditors must have five years or more direct experience in the field of med-ical cannabis cultivation and processing or five years or more direct experience in the field of agriculturalinspection and must demonstrate a thorough understanding of the standard operating systems associated withall modalities of cannabis cultivation.
Manufacturing, packaging, labeling, and holding auditors must have five years or more direct experience in thefield of medical cannabis manufacturing and are required to be food-safe certified; or have three years or moredirect experience in the inspection and auditing of facilities engaged in the manufacturing of food, food prod-ucts, or botanical and nutraceutical products. In addition, all manufacturing, packaging, labeling, and holdingauditors must also demonstrate a fundamental knowledge of any extraction processes used in the medicalcannabis industry.
PFC Laboratory auditors must have, at minimum, a degree in biochemistry; or a minimum of five years experi-ence providing laboratory analysis of medical cannabis and medical cannabis-derived products the equivalentexperience providing laboratory analysis of other raw botanicals, botanical products, or nutriceutical products.
Dispensary auditors must have, at a minimum, three years of direct experience in managing a medical cannabisdistribution facility offering patient services, or the equivalent experience offering patient services and manag-ing a traditional or Complementary Alternative Medicine facility.
X. Fees and Discounts
Each applicant has its own unique characteristics that will determine the cost of certification. Two key elementscomprise the cost of certification: size and complexity of the operations. As the size of a company increasesso does the number of patients or consumers engaging in the company’s services or products. PFC’s patientand caregiver education program serves to provide your business with plenty of educational materials designedto help consumers understand the importance of the PFC seal of approval.
All quotes also include the cost of the initial pre-certification audit plus the required compliance audit. As acompany grows in size and possibly in complexity of operations so does the amount of time necessary to con-duct a thorough audit of the company’s operations. For example, a company that dispenses medical cannabisoften requires much less time to conduct an audit than a company that cultivates and manufactures medicalcannabis. As such these scalable costs are reflected in the PFC quote.
PFC will provide a quote after a complete review of your application. This quote is an estimated cost and willinclude:
1. Fees for preliminary assessment (optional)
2. Fees for the initial audit plus one unannounced compliance audit and certification review
3. Fees for certification including graphics and promotional literature
4. Fees for ongoing compliance including complain hotline, complaint investigation, and possiblecertification challenges
PFC is committed to providing your company with a quality certification program that adds value to your busi-ness. We are committed to providing the most qualified inspection and audit team at the lowest cost possible.The program’s value drivers include:
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1. No application fee
2. Discounts for some trade association members, AHPA members, and UFCW contracted businesses.
3. No mandatory preliminary site visit
4. No hidden costs, overtime charges, or penalties for properly noticed schedule changes
5. Reimbursable expenses are charged at cost without mark-ups
6. Advanced off-site preparation is completed by PFC, reducing travel time required
7. Audits include a review of compliance with local and state regulations
8. Press release development by PFC outreach staff
9.` Advertisement of your participation in all PFC ads
Discount Opportunity: PFC is pleased to offer discounts to members of organizations that have endorsed thePFC program. Endorsing organization discounts can be combined to provide your business with a maximum15% discount on certification. PFC can also offer group discounts for organizations that want certify 10 mem-bers, or more, at a given time. For more information on endorsing organizations please see the website:www.patientfocusedcertification.org
Endorsement Opportunity for Trade Associa-tions and other Accrediting Groups: PFC recognizes theimportance of endorsing organizations ongoing work with their members to insure compliance with local andstate regulatory guidelines. As such, PFC is pleased to offer discounts to organizations working directly withthe PFC program. Once PFC has approved your association’s or accrediting group’s endorsement , PFC will hap-pily offer all members and companies acknowledged by your group a 5% discount on PFC certification.
XI. About ASA, AHPA and AHP
Founded in 2002, Americans for Safe Access (ASA) is the largest organization ofpatients, medical professionals, scientists and concerned citizens promoting safeand legal access to medical cannabis. ASA’s mission is to ensure safe and legalaccess to cannabis (marijuana) for therapeutic uses and research. ASA works with
our grassroots base of over 50,000 members to effect change using public education and direct advocacy at thelocal, state, and federal level. ASA trains and educates patients, advocates, health care professionals and otherstakeholders. ASA also provides direct legal support and uses impact litigation to protect and expand patients’rights.
As patient advocates, ASA has worked to create laws and regulations that foster the rights of patients, andensure access to safe and legal medical cannabis. Now, through PFC, patients, caregivers, and health care practi-tioners, as well as state and local regulators, can rely on the PFC seal of approval and know the medicalcannabis or cannabis-derived product has been produced in a manner that is not only compliant with local andstate laws but also with a commitment to product safety. To learn more about ASA go to: www.americansfor-safeaccess.org.
The American Herbal Products Association chartered a Cannabis Committee in 2010to meet the needs its members who cultivate, manufacture, or distribute medicalcannabis in the states where its use is allowed by state law, and of companies thatmarket industrial hemp products. AHPA has been the principal U.S. trade associa-
tion and voice of the herbal products industry since 1982. AHPA promotes the economic health of the herbalproducts industry and promotes high quality herbal and nutraceutical products. AHPA serves its members bypromoting the responsible commerce of products that contain herbs and that are used to enhance health andquality of life. To learn more about AHPA go to: www.ahpa.org.
The American Herbal Pharmacopoeia was formed in 1994 to promote the respon-sible use of herbal products and herbal medicines. AHP is a worldwide network ofbotanists, chemists, herbalists, medical doctors, pharmacists, pharmacologists, and
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other experts in medicinal plants. AHP has published monographs for 28 different botanicals, including AloeVera Leaf, American Ginseng Root, and Echinacea. The organization expects to eventually publish more than300 monographs, covering the most widely used western, Ayurvedic, and Chinese botanicals. To learn moreabout the AHP go to: www.herbal-ahp.org.
XII. Frequently Asked Questions
What is Third-Party Certification?
Third-party certification ensures that an independent organization has reviewed the cultivation and/or manu-facturing process of a product or the management process of a service in order to determine that the finalproduct complies with a specific set of standards designed to ensure safety, quality, or performance. PFC certi-fies compliance with AHPA and AHP standards for medical cannabis products and services. This review typicallyincludes comprehensive reviews of formulations and materials, independent testing, and facility inspections.Certified products typically exhibit the certifier’s ‘mark’ on their packaging to help consumers make educateddecisions about the products or services they are purchasing. PFC requires annual inspections, unannouncedrandom inspections, employee training and product testing to ensure that certified companies continue tomeet all AHPA standards after the initial certification. Other nationally recognized certification programsinclude Good Housekeeping, NSF and ISO.
What is the difference between PFC and ISO 17025 for Lab Certification?
ISO compliance will help an operator pass a PFC inspection. ISO 17025 accreditation ensures compliance with aspecific set of laboratory methods, PFC compliance ensures compliance with botanical health and safety stan-dards, and criteria for validating specific methods. Both PFC and ISO require significant documentation andmethod validation, but ISO depends on the operators being forthright whereas PFC compliance hinges on theoperator providing requested documentation i.e. ISO (e.g., 17025) audits whatever an operator presents as partof a “quality manual.” There could be a 1,000 procedures being used in the lab and only 1 could be in thequality manual. For an ISO audit, an operator is expected to show/help auditors identify “conflict” or correctiveaction areas, while PFC asks for specific criteria provided by the AHPA’s Recommendations to Regulators andthe AHP Cannabis Monograph..
ISO is used for commercial labs operating outside stateliness, laboratories are encouraged to get ISO but eventheir guidebooks suggest that local guidelines and standards are important for operating locally, if such guide-lines are available. ISO is often used when there is absence of a compliance or certification body, such as in asmall country with a few labs.
ISO is context deficient for medical cannabis operators. It doesn't tell you if the business is a good cannabisoperation or not because it only informs on what is needed to do an aspect of their work, regardless if it islegal or meant for human consumption. PFC offers training in specific areas of cannabis that are used by opera-tors and health department inspectors in compliance audits, ISO does not require that the staff be trained inspecific areas essential for operation in the cannabis industry. Sample handling, storage, security, legal opera-tions issues (ISO does not check licensing or permits from the state) are examples of best practices and regulato-ry requirements that ISO does not fully address for the cannabis industry.
Analytical Chemistry cannot be properly dealt with if its relationships with written standards are not taken intoaccount in order to efficiently contribute to the continuous improvement of human activities.
…the key issue in selecting an accreditation body is to ensure that it has recognition in the context inwhich the laboratory’s data needs to be used. Where a laboratory operates purely in a domestic marketand where the data is used only within the country, for example for local food safety or environmentalprotection, then a national accreditation body, even one with no international recognition, will normallybe entirely suitable.
(From “Complying with ISO 17025: A practical guidebook for meeting the requirements �of laboratory accreditation schemes based on ISO17025:2005� or equivalent national standards published by (United Nations Industrial Development Organization)
Difference Between PFC and ISO for Lab Certification
PFC and ISO Harmonization
• Mutual Recognition Agreements (MRAs), ISO:17011 compliance• European Cooperation for the Accreditation of Laboratories (EAL)
• Asia Pacific Accreditation Cooperation (APLAC) • Quality Systems Training• Method Validation reports• Audits
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APPLICATIONPatient Focused Certification
For your free quote, please completely fill out the application below. Upon completion, andsubmitting the application, your company’s information will be securely transmitted to PFCstaff. You will automatically receive a confirmation email verifying that PFC has received yourapplication and inviting you to create a secure PFC client profile where you can safely viewand store documents to track your company’s certification process. Within 7 business days,PFC staff will send you a price quote and contract that will list the responsibilities of all partiesinvolved including financial obligations, nondisclosure agreements and acceptance of terms.
Business Trade Name (required) ____________________________________________________________________
Business Legal Name (required) ____________________________________________________________________
Mailing Street Address:___________________________________________________________________________
City: ______________________________________________ State:__________ Zip:_____________________
Primary Contact Name (required) ______________________________________________
Primary Contact Email (required) ______________________________________________
Primary Contact Phone (required)______________________________________________
Number of Facilities (required) ________________________________(Organizations with multiple locations, please fill out Additional Locations section at the end of the application.)
Number of Employees (required) _______________________________
A. Service Requested (check all that apply) � Advisory Services � Pre-Licensing Certification � Industry Certification
B. Facilities to be Certified / Types of Certification Sought (check one)
� Cultivation � Distribution � Manufacturing � Laboratory � Cultivation & Distribution
� Cultivation & Manufacturing � Manufacturing & Distribution � Cultivation, Manufacturing, & Distribution
How many square ft of cultivated space (if applicable)
� 0-5,000 � 5,000-10,000 � 10,000-20,000 � 20,000-40,000 � 40,000 or above
Number of products manufactured (if applicable): _____________
Please describe the types of products to be manufactured (choose all that apply)
� Extracts/Concentrates � Edible or Ingestible Products � Topical Products
Additional Product Information__________________________________________________________________
_________________________________________________________________________________________
C. Licensing. Please describe the state and local licensing or registrations relevant to your operations. Please note if no li-
censes are available for your operation. ___________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
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PATIENT FOCUSED CERTIFICATION APPLICATION ~ Page 2 of 3
D. MACHINERY AND INFRASTRUCTUREPlease describe the major machinery, software and infrastructure used in your operations. Thismight include inventory and tracking software, manufacturing equipment, trim machines, etc.
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
E. SUBCONTRACTORSIf applicable, please list any sub-contractors used in your operations, including name and the activi-ties they perform. Examples of sub-contractors include the nursery that provides the company’spropagation material. Or, if manufacturing edible products, the name of the company who sup-plies your company with extracted cannabis products.
____________________________________________________________________________________________
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____________________________________________________________________________________________
____________________________________________________________________________________________
F. OTHER CERTIFICATIONSPlease list any certifications, past or present, your operation has received and the name of the certi-fying organization. If cancelled or no longer current, please describe why.
____________________________________________________________________________________________
____________________________________________________________________________________________
G. ORGANIZATION AFFILIATIONCompanies with membership in AHPA, various trade organizations, or those under UFCW contractsare eligible for discounts. Please choose all that apply:
� American Herbal Products Association
� United Food & Commercial Workers Union
� Emerald Growers Association
� International Hemp Association
� Coalition for Cannabis Standards and Ethics
Please list additional organizational memberships or affiliations: ________________________________
____________________________________________________________________________________________
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If you belong to an organization or association whose members would benefit from a discount,please contact us for details. [email protected]
CONFIDENTIA
L
PATIENT FOCUSED CERTIFICATION APPLICATION ~ Page 3 of 3
PATIENT FOCUSED CERTIFICATION, a project of Americans for Safe Access1806 Vernon Street NW, Washington, D.C. 20009
Phone: (202) 857-4272 Fax: (202) 618-6977
H. ADDITIONAL LOCATIONS
Name _______________________________________________________________________________________
Address:______________________________________________________________________________________
City: ______________________________________________ State:__________ Zip:_____________________
Type (choose one): � Cultivation � Distribution � Manufacturing
Number of Employees __________________________________
Name _______________________________________________________________________________________
Address:______________________________________________________________________________________
City: ______________________________________________ State:__________ Zip:_____________________
Type (choose one): � Cultivation � Distribution � Manufacturing
Number of Employees __________________________________
Name _______________________________________________________________________________________
Address:______________________________________________________________________________________
City: ______________________________________________ State:__________ Zip:_____________________
Type (choose one): � Cultivation � Distribution � Manufacturing
Number of Employees __________________________________
I. Where did you hear about us?
� Mail � Peer � Internet
� Organization or Association (Please list): ____________________________________________________
� Other: ___________________________________________________________________________________
All application information shall remain CONFIDENTIAL. Based on the information contained inthis application, PFC will prepare a no-obligation offer for certification. If PFC staff requires additional information to generate a quote, a representative will contact you directly via email.
A1.
1 (b
) • S
ubje
ct o
pera
tions
– D
oes t
his c
ultiv
atio
n op
erat
ion
also
incl
ude
a
proc
essi
ng o
pera
tion?
☐
☐
☐
A1.
1 (a
) • S
ubje
ct o
pera
tions
– Is
this
ope
ratio
n su
bjec
t to
stat
e an
d/or
loca
l ov
ersi
ght?
☐
☐
☐
A1.
2 • O
ther
stat
utor
y pr
ovis
ions
and
reg
ulat
ions
– Is
this
ope
ratio
n co
mpl
iant
with
all
appl
icab
le re
gula
tions
in th
e ju
risdi
ctio
n it
oper
ates
? (e
.g.
has a
lice
nse
in g
ood
stan
ding
, cer
tific
ate
of o
ccup
ancy
, con
fiden
tialit
y re
quire
men
ts, l
abel
ing
and
test
ing
requ
irem
ents
, etc
.)
☐
☐
☐
B2.
1(a)
(1) O
pera
tions
– D
oes t
he o
pera
tion
incl
ude
indo
or c
ultiv
atio
n op
erat
ions
?
☐
☐
☐
B2.
1(a)
(2) O
pera
tions
– D
oes t
he o
pera
tion
incl
ude
gree
nhou
se c
ultiv
atio
n op
erat
ions
? ☐
☐
☐
SAMPLE
B2.
1(a)
(3) O
pera
tions
– D
oes t
he o
pera
tion
incl
ude
outd
oor c
ultiv
atio
n op
erat
ions
? ☐
☐
☐
B2.
1(a)
(4) O
pera
tions
– D
oes t
he o
pera
tion
incl
ude
nurs
ery
oper
atio
ns?
☐
☐
☐
B2.
1(b)
(1) O
pera
tions
– D
oes t
his o
pera
tion
prod
uce
its o
wn
cann
abis
pl
antin
g m
ater
ial?
☐
☐
☐
B2.
1(b)
(2)(
i) O
pera
tions
– D
oes t
his o
pera
tion
obta
in c
anna
bis p
lant
ing
mat
eria
l fro
m o
ther
cul
tivat
ion
oper
atio
ns?
☐
☐
☐
B2.
1(b)
(2)(
ii) O
pera
tions
– D
oes t
his o
pera
tion
obta
in c
anna
bis f
rom
a
nurs
ery
oper
atio
n?
☐
☐
☐
B2.
1(b)
(2)(
ii) O
pera
tions
– D
oes t
his o
pera
tion
obta
in c
anna
bis f
rom
co
mpl
iant
indi
vidu
als?
☐
☐
☐
B2.
1(c)
(1) O
pera
tions
– If
this
faci
lity
cont
ains
a p
roce
ssin
g op
erat
ion,
is
cann
abis
obt
aine
d fro
m a
cul
tivat
ion
oper
atio
n?
☐
☐
☐
B2.
1(c)
(2) O
pera
tions
– If
this
faci
lity
cont
ains
a p
roce
ssin
g op
erat
ion,
is
cann
abis
obt
aine
d fro
m c
ompl
iant
indi
vidu
als?
☐
☐
☐
B2.
1(c)
(3) O
pera
tions
– If
this
faci
lity
cont
ains
a p
roce
ssin
g op
erat
ion,
is
cann
abis
obt
aine
d fro
m v
endo
rs?
☐
☐
☐
B2.
1(d)
(1) O
pera
tions
– D
oes t
his o
pera
tion
dist
ribut
e ca
nnab
is to
oth
er
culti
vatio
n op
erat
ions
? ☐
☐
☐
B2.
1(d)
(2) O
pera
tions
– D
oes t
his o
pera
tion
dist
ribut
e ca
nnab
is to
oth
er
proc
essi
ng o
pera
tions
? ☐
☐
☐
B2.
1(d)
(3) O
pera
tions
– D
oes t
his o
pera
tion
dist
ribut
e ca
nnab
is to
ope
ratio
ns
with
dis
tribu
tion
prac
tices
or d
ispen
sing
ope
ratio
ns?
☐
☐
☐
SAMPLE
B2.
1(d)
(4) O
pera
tions
– D
oes t
his o
pera
tion
dist
ribut
e ca
nnab
is to
m
anuf
actu
ring
oper
atio
ns?
☐
☐
☐
B2.
1(d)
(5) O
pera
tions
– D
oes t
his o
pera
tion
dist
ribut
e ca
nnab
is to
ven
dors
? ☐
☐
☐
B2.
1(d)
(6) O
pera
tions
– D
oes t
his o
pera
tion
dist
ribut
e ca
nnab
is to
com
plia
nt
indi
vidu
als?
☐
☐
☐
B2.
2(a)
(1) O
pera
tions
– D
oes t
his o
pera
tion
also
eng
age
in a
ncill
ary
oper
atio
ns su
ch a
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, a
nd/o
r hol
ding
of
cann
abis
-der
ived
pro
duct
s? (I
ndic
ate
all t
hose
that
app
ly b
y ci
rclin
g th
e an
cilla
ry o
pera
tion
in th
e lis
t abo
ve.)
☐
☐
☐
B2.
2(a)
(2) O
pera
tions
– D
oes t
his o
pera
tion
also
eng
age
in la
bora
tory
op
erat
ions
? ☐
☐
☐
B2.
2(a)
(3) O
pera
tions
– D
oes t
his o
pera
tion
enga
ge in
dis
tribu
tion
prac
tices
fo
r can
nabi
s and
can
nabi
s-de
rived
pro
duct
s?
☐
☐
☐
B2.
2(a)
(4) O
pera
tions
– D
oes t
his o
pera
tion
enga
ge in
cul
tivat
ion
and
mar
ketin
g of
pro
duct
s oth
er th
an c
anna
bis?
☐
☐
☐
B2.
3(a)
(1) C
ultiv
atio
n pr
actic
es –
Are
all
prop
agat
ion
mat
eria
ls u
sed
in
culti
vatio
n op
erat
ions
app
rove
d fo
r use
in fo
od p
rodu
ctio
n?
☐
☐
☐
B2.
3(a)
(1) C
ultiv
atio
n pr
actic
es –
Are
all
prop
agat
ion
mat
eria
ls h
andl
ed
follo
win
g th
e m
anuf
actu
rer’
s usa
ge, s
tora
ge, a
nd d
ispos
al re
com
men
datio
n?
☐
☐
☐
B2.
3(b)
(1)(
i-iv)
Cul
tivat
ion
prac
tices
– Is
the
oper
atio
n co
mpl
iant
with
pe
rmitt
ed u
se o
f pes
ticid
es a
s rec
omm
ende
d in
Sec
tion
2.3B
(1)(
i-iv)
and
any
ot
her a
pplic
able
regu
latio
ns fo
r the
ir ju
risdi
ctio
n?
☐
☐
☐
SAMPLE
B2.
3(b)
(2) C
ultiv
atio
n pr
actic
es –
Is th
e op
erat
ion
follo
win
g th
e m
anuf
actu
rer’
s app
licat
ion
and
stora
ge re
com
men
datio
ns, a
nd d
ispo
sal
reco
mm
enda
tions
, for
any
pes
ticid
e pr
oduc
ts?
☐
☐
☐
B2.
3(b)
(3) C
ultiv
atio
n pr
actic
es –
Is th
e op
erat
ion
follo
win
g th
e EP
A
Wor
ker P
rote
ctio
n St
anda
rd w
hen
prep
arin
g an
d ap
plyi
ng p
estic
ides
? ☐
☐
☐
B2.
3(b)
(4) C
ultiv
atio
n pr
actic
es –
If th
is o
pera
tion
is in
door
, is i
t com
plyi
ng
with
the
pest
icid
e m
anuf
actu
rer’
s pub
lishe
d re
-ent
ry in
terv
al ti
me
perio
ds
whe
n ap
plyi
ng p
estic
ides
?
☐
☐
☐
B2.
3(c)
(1) C
ultiv
atio
n pr
actic
es –
Are
the
nutri
ents
use
d in
cul
tivat
ion
appr
opria
te fo
r use
in fo
od p
rodu
ctio
n? (N
ot re
quire
d by
AH
PA d
ocum
ent.)
☐
☐
☐
B2.
3(c)
(2) C
ultiv
atio
n pr
actic
es –
Is th
e op
erat
ion
follo
win
g th
e m
anuf
actu
rer’
s app
licat
ion,
stor
age,
and
disp
osal
reco
mm
enda
tions
for t
he
nutri
ent p
rodu
ct?
☐
☐
☐
B2.
3(c)
(3) C
ultiv
atio
n pr
actic
es –
Is th
e op
erat
ion
retu
rnin
g un
used
pla
nt
solu
tions
(e.g
., ro
otin
g ho
rmon
e) to
the
sour
ce c
onta
iner
? (N
ot a
llow
ed.)
☐
☐
☐
B2.
3(c)
(4) C
ultiv
atio
n pr
actic
es –
Are
nitr
ate-
base
d an
d ot
her o
xidi
zing
fe
rtiliz
ers s
tore
d aw
ay fr
om so
lven
ts, f
uels
, and
pes
ticid
es?
☐
☐
☐
B2.
3(d)
(1) C
ultiv
atio
n pr
actic
es –
If th
e op
erat
ion
is in
door
, are
car
bon
diox
ide
leve
ls k
ept u
nder
200
0 pp
m w
hen
faci
lity
pers
onne
l may
be
pres
ent i
n cu
ltiva
tion
area
s?
☐
☐
☐
B2.
3(d)
(2) C
ultiv
atio
n pr
actic
es –
Is th
e in
door
cul
tivat
ion
faci
lity
utili
zing
ca
rbon
dio
xide
at l
evel
s abo
ve 2
000
ppm
in a
seal
ed ro
om?
If so
, is t
here
pr
otec
tive
equi
pmen
t pro
vide
d fo
r per
sonn
el a
nd w
arni
ng si
gns
pres
ent t
o pr
even
t oth
er p
erso
nnel
from
ent
erin
g?
☐
☐
☐
B2.
3(d)
(3) C
ultiv
atio
n pr
actic
es –
Are
all
regu
lato
rs a
nd e
nviro
nmen
tal
cont
rol s
yste
ms t
hat r
egul
ate
carb
on d
ioxi
de e
mis
sion
s in
good
wor
king
ord
er
☐
☐
☐
SAMPLE
and
serv
iced
in a
ccor
danc
e w
ith th
e m
anuf
actu
rer’
s rec
omm
enda
tions
?
B2.
3(e)
(1) C
ultiv
atio
n pr
actic
es –
Is e
quip
men
t use
d fo
r mea
surin
g,
regu
latin
g, o
r rec
ordi
ng te
mpe
ratu
res,
pH, h
umid
ity, o
r oth
er c
ondi
tions
re
late
d to
the
culti
vatio
n an
d pr
oces
sing
of c
anna
bis a
ccur
ate
and
adeq
uate
ly
mai
ntai
ned
(as e
vide
nt b
y do
cum
enta
tion
or m
onito
ring
in a
mai
ntai
ned
log)
?
☐
☐
☐
B2.
3(e)
(2) C
ultiv
atio
n pr
actic
es –
Are
cul
tivat
ion
and
proc
essi
ng to
ols t
hat
com
e in
dire
ct c
onta
ct w
ith c
anna
bis p
lant
s dis
infe
cted
as n
eede
d?
☐
☐
☐
B2.
3(e)
(3) C
ultiv
atio
n pr
actic
es –
Are
scal
es u
sed
for t
he w
eigh
ing
of
cann
abis
cal
ibra
ted
at re
gula
r int
erva
ls?
☐
☐
☐
B2.
4(a)
Pro
cess
ing
prac
tices
– A
re a
ll w
ork
surf
aces
and
equ
ipm
ent c
lean
an
d sa
nita
ry?
☐
☐
☐
B2.
4(b)
Pro
cess
ing
prac
tices
– A
re th
ere
prot
ocol
s in
plac
e w
hich
pre
vent
pr
oces
sing
con
tam
inat
ion
and
mol
d an
d m
ildew
gro
wth
on
cann
abis?
☐
☐
☐
B2.
4(c)
Pro
cess
ing
prac
tices
– A
re fa
cem
asks
and
glo
ves u
sed
by e
mpl
oyee
s ha
ndlin
g ca
nnab
is in
goo
d op
erab
le c
ondi
tion,
as a
pplic
able
to jo
b fu
nctio
n?
☐
☐
☐
B2.
4(d)
Pro
cess
ing
prac
tices
– D
o em
ploy
ees w
ash
hand
s suf
ficie
ntly
whe
n ha
ndlin
g ca
nnab
is o
r use
glo
ves (
with
pro
per a
nti-s
eptic
tech
niqu
es)?
☐
☐
☐
B2.
5(1)
Dis
trib
utio
n pr
actic
es –
Is th
e ca
nnab
is di
strib
uted
by
the
oper
atio
n ac
com
pani
ed w
ith th
e cu
ltiva
tion
or p
roce
ssin
g op
erat
ion’
s nam
e?
☐
☐
☐
B2.
5(2)
Dis
trib
utio
n pr
actic
es –
Is th
e ca
nnab
is di
strib
uted
by
the
oper
atio
n ac
com
pani
ed w
ith th
e ap
prop
riate
info
rmat
ion
for t
he id
entit
y of
the
cont
ents
? ☐
☐
☐
B2.
5(3)
Dis
trib
utio
n pr
actic
es –
Is th
e ca
nnab
is di
strib
uted
by
the
oper
atio
n ac
com
pani
ed w
ith th
e ap
prop
riate
info
rmat
ion
for t
he n
et w
eigh
t of c
onte
nts?
☐
☐
☐
B2.
5(4)
Dis
trib
utio
n pr
actic
es –
Is th
e ca
nnab
is di
strib
uted
by
the
oper
atio
n ☐
☐
☐
SAMPLE
acco
mpa
nied
with
suffi
cien
t inf
orm
atio
n to
trac
e th
e ca
nnab
is to
its b
atch
?
C3.
1(a)
(1) P
erso
nnel
– D
oes t
he o
pera
tion
ensu
re th
at a
ll em
ploy
ees h
ave
educ
atio
n, tr
aini
ng, a
nd e
xper
ienc
e, o
r any
com
bina
tion
ther
eof,
to e
nabl
e th
at
pers
on to
per
form
all
assi
gned
func
tions
?
☐
☐
☐
C3.
1(a)
(2) P
erso
nnel
– A
re th
ere
reco
rds o
f tra
inin
gs p
rovi
ded
to e
mpl
oyee
s fo
r the
per
form
ance
of a
ll as
sign
ed fu
nctio
ns?
☐
☐
☐
C3.
1(b)
(1) P
erso
nnel
– D
oes t
he o
pera
tion
prov
ide
all e
mpl
oyee
s with
tra
inin
g re
gard
ing
regu
lato
ry in
spec
tion
prep
ared
ness
?
☐
☐
☐
C3.
1(b)
(1) P
erso
nnel
– D
oes t
he o
pera
tion
prov
ide
all e
mpl
oyee
s with
tra
inin
g re
gard
ing
law
-enf
orce
men
t int
erac
tions
? ☐
☐
☐
C3.
1(b)
(2) P
erso
nnel
– D
oes t
he o
pera
tion
prov
ide
all e
mpl
oyee
s with
tra
inin
g re
gard
ing
U.S
. fed
eral
law
s, re
gula
tions
, and
pol
icie
s rel
atin
g to
in
divi
dual
s em
ploy
ed in
thes
e op
erat
ions
, and
the
impl
icat
ions
of t
hese
for
such
em
ploy
ees?
☐
☐
☐
C3.
1(c)
(1) P
erso
nnel
– D
oes t
he o
pera
tion
impl
emen
t em
ploy
ee h
ygie
ne
prot
ocol
s and
trai
ning
, whi
ch a
t a m
inim
um a
ddre
ss p
olic
ies w
hich
pro
hibi
t em
ploy
ees w
ho a
re sh
owin
g si
gns o
f illn
ess,
open
wou
nds,
sore
s, o
r ski
n in
fect
ions
from
han
dlin
g ca
nnab
is?
☐
☐
☐
C3.
1(c)
(2) P
erso
nnel
– D
oes t
he o
pera
tion
impl
emen
t em
ploy
ee h
ygie
ne
prot
ocol
s and
trai
ning
, whi
ch a
t a m
inim
um a
ddre
ss h
ygie
ne tr
aini
ng fo
r em
ploy
ees w
ho h
andl
e ca
nnab
is w
ith sp
ecifi
c at
tent
ion
to p
reve
ntin
g m
icro
bial
con
tam
inat
ion
(incl
udin
g a
mic
robi
al c
onta
min
atio
n pr
even
tion
man
ual o
n ha
ndlin
g ca
nnab
is a
sept
ical
ly)?
☐
☐
☐
C3.
1(c)
(3) P
erso
nnel
– D
oes t
he o
pera
tion
impl
emen
t em
ploy
ee h
ygie
ne
prot
ocol
s and
trai
ning
, whi
ch a
t a m
inim
um a
ddre
ss h
and
was
hing
re
quire
men
ts in
clud
ing
was
hing
han
ds w
ith so
ap a
nd h
ot w
ater
bef
ore
begi
nnin
g w
ork,
afte
r usi
ng th
e ba
thro
om, a
nd a
fter m
eal b
reak
s?
☐
☐
☐
SAMPLE
C3.
1(c)
(4) P
erso
nnel
– D
oes t
he o
pera
tion
have
han
d w
ashi
ng si
gnag
e in
ap
prop
riate
are
as su
ch a
s bat
hroo
ms,
kitc
hens
, and
lunc
h ar
eas,
and
in m
ultip
le
lang
uage
s as n
eede
d?
☐
☐
☐
C3.
2(a)
Em
ploy
ee sa
fety
– D
oes t
he o
pera
tion
impl
emen
t saf
ety
prot
ocol
s an
d pr
ovid
e al
l em
ploy
ees w
ith a
dequ
ate
safe
ty tr
aini
ng re
leva
nt to
thei
r sp
ecifi
c jo
b fu
nctio
ns?
☐
☐
☐
C3.
2(a)
(1) E
mpl
oyee
safe
ty –
Doe
s the
ope
ratio
n pr
ovid
e em
ploy
ees w
ith
emer
genc
y ac
tion
resp
onse
pla
nnin
g as
nec
essa
ry?
☐
☐
☐
C3.
2(a)
(2) E
mpl
oyee
safe
ty –
Doe
s the
ope
ratio
n pr
ovid
e tra
inin
g an
d pr
otoc
ols f
or e
mpl
oyee
acc
iden
t rep
ortin
g an
d in
vest
igat
ion
polic
ies?
☐
☐
☐
C3.
2(a)
(3) E
mpl
oyee
safe
ty –
Doe
s the
ope
ratio
n pr
ovid
e tra
inin
g an
d pr
otoc
ols f
or fi
re p
reve
ntio
n?
☐
☐
☐
C3.
2(a)
(4) E
mpl
oyee
safe
ty –
Doe
s the
ope
ratio
n pr
ovid
e tra
inin
g an
d pr
otoc
ols f
or h
azar
d co
mm
unic
atio
n po
licie
s, in
clud
ing
mai
nten
ance
of
mat
eria
l saf
ety
data
shee
ts (M
SDS)
?
☐
☐
☐
C3.
2(a)
(5) E
mpl
oyee
safe
ty –
Doe
s the
ope
ratio
n pr
ovid
e tra
inin
g an
d pr
otoc
ols f
or m
ater
ials
han
dlin
g, sp
ill, a
nd d
ispo
sal p
olic
ies?
☐
☐
☐
C3.
2(a)
(6) E
mpl
oyee
safe
ty –
Doe
s the
ope
ratio
n pr
ovid
e tra
inin
g an
d pr
otoc
ols f
or jo
b ha
zard
ana
lyse
s?
☐
☐
☐
C3.
2(a)
(7) E
mpl
oyee
safe
ty –
Doe
s the
ope
ratio
n pr
ovid
e tra
inin
g an
d pr
otoc
ols f
or p
erso
nal p
rote
ctiv
e eq
uipm
ent (
PPE)
pol
icie
s, in
clud
ing
resp
irato
ry p
rote
ctio
n?
☐
☐
☐
C3.
2(b)
Em
ploy
ee sa
fety
– D
oes t
he o
pera
tion
prov
ide
and
mai
ntai
n at
leas
t on
e em
erge
ncy
eye
flush
ing
stat
ion
read
ily a
cces
sibl
e to
all
empl
oyee
s and
ac
cess
to a
dequ
ate
eye
flush
ing
wat
er fo
r eac
h em
ploy
ee?
☐
☐
☐
SAMPLE
C3.
29(c
) Em
ploy
ee sa
fety
– D
oes t
he o
pera
tion
visi
bly
post
and
mai
ntai
n an
em
erge
ncy
cont
act l
ist w
hich
incl
udes
at a
min
imum
:(1) O
pera
tion
man
ager
co
ntac
ts; (
2) E
mer
genc
y re
spon
der c
onta
cts;
(3) P
oiso
n co
ntro
l con
tact
s; (4
) Fi
re d
epar
tmen
t con
tact
s; a
nd (5
) Spi
ll re
spon
se te
am c
onta
cts?
(Ind
icat
e th
e m
issi
ng e
mer
genc
y co
ntac
ts, i
f any
)
☐
☐
☐
D4.
1(a)
(1) F
acili
ties c
ompl
ianc
e –
Doe
s the
ope
ratio
n co
mpl
y w
ith a
ll le
gal
requ
irem
ents
for r
estri
ctio
ns o
n th
e si
ze o
f the
cul
tivat
ion
area
?
☐
☐
☐
D4.
1(a)
(2) F
acili
ties c
ompl
ianc
e –
Doe
s the
ope
ratio
n co
mpl
y w
ith a
ll le
gal
requ
irem
ents
for r
estri
ctio
ns o
n th
e nu
mbe
r of c
anna
bis p
lant
s allo
wed
or o
ther
qu
antit
ativ
e lim
its?
☐
☐
☐
D4.
1(a)
(3) F
acili
ties c
ompl
ianc
e –
Doe
s the
ope
ratio
n co
mpl
y w
ith a
ll le
gal
requ
irem
ents
for l
ight
pol
lutio
n re
stric
tions
? ☐
☐
☐
D4.
1(b)
(1) F
acili
ties c
ompl
ianc
e –
Is c
ultiv
atio
n op
erat
ion
loca
ted
on
prop
erty
that
is z
oned
for s
uch
use
and
loca
ted
in a
fully
per
mitt
ed, n
on-
resi
dent
ial s
truct
ure?
☐
☐
☐
D4.
1(b)
(1)(
i) Fa
cilit
ies c
ompl
ianc
e –
Is c
ultiv
atio
n op
erat
ion
cons
truct
ed in
co
mpl
ianc
e w
ith lo
cal b
uild
ing
code
s?
☐
☐
☐
D4.
1(b)
(1)(
ii) F
acili
ties c
ompl
ianc
e –
If in
door
s, do
es th
e op
erat
ion
have
a
com
plet
e ro
of e
nclo
sure
supp
orte
d by
con
nect
ing
wal
ls e
xten
ding
from
the
grou
nd to
the
roof
?
☐
☐
☐
D4.
1(b)
(1)(
iii) F
acili
ties c
ompl
ianc
e –
Is th
e op
erat
ion
secu
re a
gain
st
unau
thor
ized
ent
ry?
☐
☐
☐
D4.
1(b)
(1)(
iv) F
acili
ties c
ompl
ianc
e –
Doe
s the
ope
ratio
n m
inim
ize
unne
cess
ary
visu
al, a
udito
ry, o
r olfa
ctor
y ev
iden
ce o
f ind
oor c
anna
bis
culti
vatio
n?
☐
☐
☐
D4.
1(b)
(2) F
acili
ties c
ompl
ianc
e –
If th
ere
is a
n ou
tdoo
r cul
tivat
ion
oper
atio
n an
d/or
gre
enho
use
culti
vatio
n op
erat
ion
loca
ted
on a
pro
perty
, is i
t zon
ed fo
r ☐
☐
☐
SAMPLE
such
use
?
D4.
1(b)
(3) F
acili
ties c
ompl
ianc
e –
Is th
e ou
tdoo
r cul
tivat
ion
oper
atio
n an
d/or
gr
eenh
ouse
ope
ratio
ns lo
cate
d w
ithin
any
setb
acks
that
per
tain
to th
e pr
oper
ty?
☐
☐
☐
D4.
1(b)
(4) F
acili
ties c
ompl
ianc
e –
If th
e op
erat
ion
incl
udes
a g
reen
hous
e, is
th
e gr
eenh
ouse
cul
tivat
ion
stru
ctur
e fu
lly p
erm
itted
and
bui
lt to
cod
e?
☐
☐
☐
D4.
1(c)
(1) F
acili
ties c
ompl
ianc
e –
If th
ere
is a
pro
cess
ing
oper
atio
n, is
it
loca
ted
on a
pro
perty
that
is z
oned
for s
uch
use?
☐
☐
☐
D4.
1(c)
(2) F
acili
ties c
ompl
ianc
e –
If th
ere
is a
pro
cess
ing
oper
atio
n, is
it
loca
ted
with
in a
ny se
tbac
ks th
at p
erta
in to
the
prop
erty
whe
re th
e pr
oces
sing
is
taki
ng p
lace
?
☐
☐
☐
D4.
1(c)
(3) F
acili
ties c
ompl
ianc
e –
If th
ere
is a
pro
cess
ing
oper
atio
n, is
the
stru
ctur
e fu
lly p
erm
itted
and
con
struc
ted
in c
ompl
ianc
e w
ith lo
cal b
uild
ing
code
?
☐
☐
☐
D4.
1(d)
Fac
ilitie
s com
plia
nce
– D
oes t
he o
utdo
or c
ultiv
atio
n or
gre
enho
use
culti
vatio
n op
erat
ion
(if a
ny) s
hiel
d or
dow
ncas
t sup
plem
enta
l lig
htin
g?
☐
☐
☐
D4.
1(e)
Fac
ilitie
s com
plia
nce
– D
oes t
he o
pera
tion
trans
port
cann
abis
in a
se
cure
d en
clos
ed c
onta
iner
or s
ecur
ed tr
unk
of th
e de
liver
y ve
hicl
e?
☐
☐
☐
D4.
2(a)
Fac
ilitie
s fir
e pr
even
tion
– A
re th
e ro
oms o
f the
indo
or c
ultiv
atio
n op
erat
ion
(if a
ny) i
n w
hich
ope
ratio
nal s
uppl
emen
tal l
ight
ing,
bal
last
s, or
el
ectri
cal c
ontro
l pan
els a
re lo
cate
d co
nstru
cted
with
a m
inim
um o
f a o
ne-h
our
firew
all a
ssem
bly?
☐
☐
☐
D4.
2(b)
(1) F
acili
ties f
ire
prev
entio
n –
Doe
s the
ope
ratio
n pr
ovid
e at
leas
t on
e op
erat
ing
fire
extin
guis
her?
☐
☐
☐
D4.
2(b)
(2) F
acili
ties f
ire
prev
entio
n –
Doe
s the
ope
ratio
n pr
ovid
e ad
ditio
nal
fire
extin
guis
hers
in a
num
ber p
ropo
rtion
al to
the
wat
ts o
f sup
plem
enta
l lig
htin
g us
ed in
the
faci
lity
(one
fire
ext
ingu
ishe
r per
eve
ry 1
0,00
0 w
atts
of
☐
☐
☐
SAMPLE
light
ing)
, or i
n ac
cord
ance
with
loca
l fire
cod
e?
D4.
2(c)
(1) F
acili
ties f
ire
prev
entio
n –
Are
the
fire
extin
guis
hers
eas
ily
acce
ssib
le to
em
ploy
ees f
rom
eve
ry ro
om a
nd in
eac
h ha
llway
of t
he fa
cilit
y?
☐
☐
☐
D4.
2(c)
(2) F
acili
ties f
ire
prev
entio
n –
Are
the
fire
extin
guis
hers
mai
ntai
ned
annu
ally
or a
s oth
erw
ise
spec
ified
by
the
man
ufac
ture
r?
☐
☐
☐
D4.
2(c)
(3) F
acili
ties f
ire
prev
entio
n –
Are
the
fire
extin
guis
hers
of t
he
appr
opria
te c
lass
ratin
g fo
r the
type
of f
ire a
ssoc
iate
d w
ith th
e fu
nctio
ns b
eing
pe
rform
ed in
the
faci
lity
(e.g
., el
ectri
cal,
chem
ical
)?
☐
☐
☐
D4.
2(d)
Fac
ilitie
s fir
e pr
even
tion
– A
re fl
amm
able
pro
duct
s sto
red
in a
pr
oper
ly m
arke
d fir
e co
ntai
nmen
t cab
inet
or a
rea?
☐
☐
☐
D4.
2(e)
Fac
ilitie
s fir
e pr
even
tion
– D
oes t
he o
pera
tion
have
sign
age
that
co
mpl
ies w
ith N
atio
nal F
ire P
rote
ctio
n A
ssoc
iatio
n (N
FPA
) sta
ndar
d 70
4?
☐
☐
☐
D4.
3(a)
Fac
ilitie
s san
itatio
n –
Doe
s the
ope
ratio
n pr
ovid
e em
ploy
ees w
ith
adeq
uate
and
read
ily-a
cces
sibl
e to
ilet f
acili
ties?
☐
☐
☐
D4.
3(a)
(1) F
acili
ties s
anita
tion
– D
oes o
pera
tion
prov
ide
empl
oyee
s with
ad
equa
te a
nd re
adily
-acc
essi
ble
toile
t fac
ilitie
s tha
t are
mai
ntai
ned
in a
sa
nita
ry c
ondi
tion?
☐
☐
☐
D4.
3(a)
(2) F
acili
ties s
anita
tion
– D
oes o
pera
tion
prov
ide
empl
oyee
s with
ad
equa
te a
nd re
adily
-acc
essi
ble
toile
t fac
ilitie
s tha
t are
ade
quat
ely
stoc
ked
with
toile
t pap
er, s
oap,
and
sing
le-u
se p
aper
tow
els o
r oth
er d
ryin
g de
vice
s?
☐
☐
☐
D4.
3(a)
(3) F
acili
ties s
anita
tion
– D
oes o
pera
tion
prov
ide
empl
oyee
s with
ad
equa
te a
nd re
adily
-acc
essi
ble
toile
t fac
ilitie
s tha
t are
kep
t in
good
repa
ir at
al
l tim
es?
☐
☐
☐
D4.
3(b)
Fac
ilitie
s san
itatio
n –
Doe
s the
ope
ratio
n pr
ovid
e ad
equa
te a
nd
conv
enie
nt h
and-
was
hing
stat
ions
? ☐
☐
☐
SAMPLE
D4.
3(b)
(1) F
acili
ties s
anita
tion
– D
oes t
he o
pera
tion
prov
ide
hand
-was
hing
st
atio
ns w
ith ru
nnin
g w
ater
of s
uita
ble
tem
pera
ture
? ☐
☐
☐
D4.
3(b)
(2) F
acili
ties s
anita
tion
– D
oes t
he o
pera
tion
prov
ide
hand
-was
hing
st
atio
ns st
ocke
d w
ith e
ffect
ive
hand
-cle
anin
g or
sani
tizin
g pr
epar
atio
ns a
nd
sing
le-u
se p
aper
tow
els o
r oth
er d
ryin
g de
vice
s?
☐
☐
☐
D4.
3(b)
(3) F
acili
ties s
anita
tion
– D
oes t
he o
pera
tion
prov
ide
hand
-was
hing
st
atio
ns lo
cate
d at
poi
nts i
n th
e fa
cilit
y w
here
goo
d sa
nita
ry p
ract
ices
requ
ire
empl
oyee
s to
was
h or
sani
tize
thei
r han
ds?
☐
☐
☐
D4.
3(b)
(4) F
acili
ties s
anita
tion
– D
oes t
he o
pera
tion
prov
ide
hand
-was
hing
st
atio
ns a
t fie
ld lo
catio
ns a
s app
ropr
iate
? ☐
☐
☐
D4.
3(c)
(1) F
acili
ties s
anita
tion
– D
oes t
he o
pera
tion
impl
emen
t san
itatio
n pr
actic
es th
at a
ddre
ss re
mov
al o
f deb
ris?
☐
☐
☐
D4.
3(c)
(1) F
acili
ties s
anita
tion
– D
oes t
he o
pera
tion
impl
emen
t san
itatio
n pr
actic
es fo
r the
con
trol o
f the
gro
wth
of m
old,
mild
ew, a
nd a
lgae
in th
e cu
ltiva
tion
area
or p
roce
ssin
g ar
ea?
☐
☐
☐
D4.
3(c)
(2) F
acili
ties s
anita
tion
– D
oes t
he o
pera
tion
impl
emen
t pes
t con
trol
prac
tices
, inc
ludi
ng m
aint
enan
ce a
nd re
pair
of c
aulk
cra
cks a
nd d
rain
are
as?
☐
☐
☐
D4.
3(c)
(3) F
acili
ties s
anita
tion
– D
oes t
he o
pera
tion
impl
emen
t pra
ctic
es fo
r th
e id
entif
icat
ion
of h
oses
ded
icat
ed fo
r use
in c
ultiv
atio
n?
☐
☐
☐
D4.
3(c)
(4) F
acili
ties s
anita
tion
– D
oes t
he o
pera
tion
impl
emen
t pra
ctic
es fo
r m
aint
enan
ce a
nd c
lean
ing
of ir
rigat
ion
syst
ems?
☐
☐
☐
D4.
3(d)
Fac
ilitie
s san
itatio
n –
Doe
s the
pro
cess
ing
oper
atio
n pr
otec
t can
nabi
s fro
m c
onta
ct w
ith b
irds,
rode
nts,
inse
cts,
and
othe
r ani
mal
s and
from
exp
osur
e to
the
elem
ents
?
☐
☐
☐
D4.
4(a)
Fac
ilitie
s ele
ctri
cal –
Is th
e op
erat
ion’
s ele
ctric
al sy
stem
of s
uffic
ient
ca
paci
ty to
han
dle
the
actu
al e
lect
rical
load
and
inst
alle
d in
acc
orda
nce
with
an
☐
☐
☐
SAMPLE
appr
oved
ele
ctric
al p
erm
it?
D4.
4(b)
Fac
ilitie
s ele
ctri
cal –
Hav
e al
l ele
ctric
al w
ork
and
upgr
ades
bee
n pe
rform
ed w
ith p
rope
r per
mitt
ing?
☐
☐
☐
D4.
4(c)
Fac
ilitie
s ele
ctri
cal –
Is a
ll th
e el
ectri
cal e
quip
men
t con
nect
ed to
the
elec
trica
l sys
tem
in a
ccor
danc
e w
ith th
e eq
uipm
ent m
anuf
actu
rer’
s re
com
men
datio
ns?
☐
☐
☐
D4.
5(a)
Fac
ilitie
s ven
tilat
ion
– Is
the
oper
atio
n eq
uipp
ed w
ith a
dequ
ate
vent
ilatio
n to
mai
ntai
n pr
oper
hum
idity
and
tem
pera
ture
? ☐
☐
☐
D4.
5(b)
(1) F
acili
ties v
entil
atio
n –
Doe
s the
indo
or c
ultiv
atio
n op
erat
ion'
s m
echa
nica
lly p
rope
lled
air i
ntak
e sy
stem
use
a fi
lter c
apab
le o
f rem
ovin
g 99
.97%
of p
artic
les w
ith a
dia
met
er o
f 0.3
mic
rom
eter
s (µm
) to
cont
rol
pote
ntia
l con
tam
inat
ion
with
pat
hoge
nic
orga
nism
s?
☐
☐
☐
D4.
5(b)
(2) F
acili
ties v
entil
atio
n –
Doe
s the
indo
or c
ultiv
atio
n op
erat
ion'
s no
n-m
echa
nica
lly p
rope
lled
or p
assi
ve in
take
syst
em u
se a
gra
te a
nd fi
lter
suffi
cien
t to
redu
ce th
e in
trusio
n of
rode
nts a
nd in
sect
s?
☐
☐
☐
D4.
6(a)
Fac
ilitie
s dis
posa
l – Is
can
nabi
s was
te d
ispo
sal d
ocum
ente
d, d
one
in
a m
anne
r whi
ch p
reve
nts u
naut
horiz
ed u
se, a
nd c
ompl
iant
with
any
re
gula
tions
and
reco
mm
enda
tions
in th
e ju
risdi
ctio
n in
whi
ch it
ope
rate
s?
☐
☐
☐
D4.
6(b)
Fac
ilitie
s dis
posa
l – A
re b
ulbs
and
bal
last
s dis
pose
d of
in a
ccor
danc
e w
ith m
anuf
actu
rer’
s rec
omm
enda
tions
? ☐
☐
☐
D4.
7(a)
Fac
ilitie
s sec
urity
– Is
the
outd
oor a
nd/o
r gre
enho
use
culti
vatio
n op
erat
ion
encl
osed
by
a se
cure
per
imet
er fe
nce
at le
ast s
ix (6
) fee
t in
heig
ht
that
incl
udes
a lo
ckab
le g
ate
that
is lo
cked
and
doe
s not
vio
late
any
oth
er
ordi
nanc
e, c
ode
sect
ion
or p
rovi
sion
of la
w re
gard
ing
heig
ht a
nd lo
catio
n re
stric
tions
?
☐
☐
☐
D4.
7(b)
Fac
ilitie
s sec
urity
– D
oes t
he in
door
cul
tivat
ion
faci
lity
or p
roce
ssin
g fa
cilit
y ha
ve lo
ckin
g do
ors a
nd w
indo
ws w
hich
allo
w e
mer
genc
y in
gres
s and
☐
☐
☐
SAMPLE
egre
ss in
acc
orda
nce
with
app
licab
le re
gula
tions
?
D4.
7(c)
Fac
ilitie
s sec
urity
– D
oes t
he o
pera
tion
impl
emen
t and
com
mun
icat
e se
curit
y pr
otoc
ols t
o al
l per
sonn
el?
☐
☐
☐
D4.
7(d)
Fac
ilitie
s sec
urity
– D
oes t
he o
pera
tion
mai
ntai
n a
visi
tor l
og a
nd
have
a p
olic
y re
quiri
ng v
isito
rs to
be
acco
mpa
nied
by
an e
mpl
oyee
at a
ll tim
es?
☐
☐
☐
E5.
1(a)
Wat
er R
esou
rce
culti
vatio
n –
Is th
e op
erat
ion
follo
win
g lo
cal o
r st
ate
wat
er d
istri
ct re
gula
tions
for c
anna
bis p
rodu
ctio
n or
impl
emen
ting
a cu
ltiva
tion
wat
er m
anag
emen
t pla
n?
☐
☐
☐
E5.
1(a)
(1) W
ater
Res
ourc
e cu
ltiva
tion
– D
oes t
he c
ultiv
atio
n w
ater
m
anag
emen
t pla
n ad
dres
s ero
sion
pre
vent
ion?
☐
☐
☐
E5.
1(a)
(2) W
ater
Res
ourc
e cu
ltiva
tion
– D
oes t
he c
ultiv
atio
n w
ater
m
anag
emen
t pla
n ad
dres
s effl
uent
and
agr
icul
tura
l dis
char
ges?
☐
☐
☐
E5.
1(b)
Wat
er R
esou
rce
culti
vatio
n –
Is th
e op
erat
ion
disp
osin
g of
che
mic
al
solu
tions
in a
ccor
danc
e w
ith a
pplic
able
law
s and
regu
latio
ns?
☐
☐
☐
E5.
1(c)
Wat
er R
esou
rce
culti
vatio
n –
Is th
e ap
plic
atio
n of
nut
rient
s or
pest
icid
es th
roug
h an
irrig
atio
n sy
stem
(che
mig
atio
n) p
erfo
rmed
in a
ccor
danc
e w
ith st
ate
or lo
cal a
gric
ultu
ral r
egul
atio
ns?
☐
☐
☐
E5.
2(a)
Wat
er R
esou
rce
pota
ble
– If
the
oper
atio
n is
not
util
izin
g a
mun
icip
al so
urce
of p
otab
le w
ater
, is t
he o
pera
tion
test
ing
the
pota
ble
wat
er
supp
ly a
t lea
st tw
o tim
es p
er y
ear t
o en
sure
com
plia
nce
with
stat
e pr
imar
y dr
inki
ng w
ater
stan
dard
s?
☐
☐
☐
E5.
2(b)
Wat
er R
esou
rce
pota
ble
– A
re c
hem
ical
s, fe
rtiliz
ers,
pest
icid
es,
med
ia, a
nd o
ther
pro
duct
s sto
red
away
from
the
pota
ble
wat
er su
pply
? ☐
☐
☐
F6(a
) Rec
ordk
eepi
ng –
Doe
s the
ope
ratio
n ha
ve re
cord
s to
iden
tity
and
sour
ce a
ll ca
nnab
is p
ropa
gatio
n m
ater
ial w
ith su
ffici
ent s
peci
ficity
to e
nsur
e ☐
☐
☐
SAMPLE
that
the
mat
eria
l can
be
trace
d to
its s
ourc
e?
F6 (b
)(1)
(i-iv
) Rec
ordk
eepi
ng –
Doe
s the
ope
ratio
n m
aint
ain
plan
ting
reco
rds f
or e
ach
batc
h of
can
nabi
s tha
t inc
lude
at a
min
imum
: i) F
orm
of
cann
abis
pla
nted
(e.g
., se
ed, c
lone
, see
dlin
gs, e
tc.);
(ii)
Dat
e(s)
that
pla
ntin
g to
ok p
lace
; (iii
) Var
iety
(ies)
pla
nted
; (iv
) Siz
e of
the
culti
vatio
n ar
ea; a
nd (v
) Lo
catio
n of
the
culti
vatio
n ar
ea?
(Ind
icat
e an
y pa
ram
eter
s tha
t are
mis
sing
fro
m p
lant
ing
reco
rds)
☐
☐
☐
F6 (b
)(2)
Rec
ordk
eepi
ng p
ropa
gatio
n –
Doe
s the
ope
ratio
n m
aint
ain
prop
agat
ion
reco
rds f
or e
ach
batc
h of
can
nabi
s tha
t inc
lude
at a
min
imum
: (i)
Med
ia u
sed
and
whe
ther
the
med
ia w
as re
used
or n
ew p
rodu
ct; (
ii) D
escr
iptio
n of
all
actio
ns ta
ken
to p
reve
nt d
isea
se o
r pes
t iss
ues
or tr
eat t
he c
anna
bis f
or
them
; (iii
) Soi
l am
endm
ents
add
ed a
nd st
reng
th o
f the
app
licat
ion;
(iv)
N
utrie
nts a
dded
and
stre
ngth
of t
he a
pplic
atio
n; (v
) All
subs
tanc
es a
pplie
d to
th
e pl
ant(s
) sur
face
or u
sed
as a
fum
igan
t in
the
culti
vatio
n an
d/or
nur
sery
ar
ea; a
nd (v
i) Pr
unin
g or
oth
er p
hysi
cal t
echn
ique
(s)?
(Ind
icat
e an
y pa
ram
eter
s th
at a
re m
issi
ng fr
om p
ropa
gatio
n re
cord
s.)
☐
☐
☐
F6(b
)(3)
Rec
ordk
eepi
ng p
estic
ide
– D
oes t
he o
pera
tion
mai
ntai
n pe
stic
ide
reco
rds f
or e
ach
batc
h of
can
nabi
s tha
t inc
lude
at a
min
imum
: (i)
Pest
icid
e ch
emic
al n
ame;
(ii)
Bra
nd n
ame
and
man
ufac
ture
r nam
e; (i
ii) A
mou
nt o
f pe
stic
ide
appl
ied;
(iv)
Dat
e pe
stic
ide
appl
ied;
(v) I
dent
ifica
tion
or lo
catio
n of
pl
ants
to w
hich
pes
ticid
e w
as a
pplie
d; a
nd (v
i) N
ame
of a
pplic
ator
, if
requ
ired?
(Ind
icat
e an
y pa
ram
eter
s tha
t are
mis
sing
from
pes
ticid
e re
cord
s.)
☐
☐
☐
F6(b
)(4)
Rec
ordk
eepi
ng h
arve
st –
Doe
s the
ope
ratio
n m
aint
ain
harv
est
reco
rds f
or e
ach
batc
h of
can
nabi
s tha
t inc
lude
at a
min
imum
: (i)
Iden
tity
of
each
var
iety
har
vest
ed; (
ii) D
ate
of h
arve
st; (
iii) G
ross
wei
ght o
f the
can
nabi
s ha
rves
ted
for p
roce
ssin
g (g
ener
ally
reco
rded
afte
r dry
ing)
; (iv
) Tot
al w
eigh
t of
can
nabi
s was
te re
sulti
ng fr
om th
e ha
rves
t; an
d (v
) Net
wei
ght o
f har
vest
ed
cann
abis
(gro
ss w
eigh
t les
s was
te)?
(Ind
icat
e an
y pa
ram
eter
s tha
t are
mis
sing
fro
m h
arve
st re
cord
s.)
☐
☐
☐
F6(c
) Rec
ordk
eepi
ng p
roce
ssin
g –
Doe
s the
ope
ratio
n m
aint
ain
proc
essi
ng
reco
rds f
or e
ach
batc
h of
can
nabi
s tha
t inc
lude
at a
min
imum
: (1)
Iden
tity
of
the
varie
ty p
roce
ssed
; (2)
Suf
ficie
nt in
form
atio
n to
trac
e th
e pr
oces
sed
☐
☐
☐
SAMPLE
cann
abis
to it
s cul
tivat
ion
sour
ce; (
3) D
ate
of p
roce
ssin
g; (4
) Ini
tial w
eigh
t; an
d (5
) Tot
al w
eigh
t of a
ny p
roce
ssin
g lo
ss (b
ased
on
wet
or d
ry w
eigh
t)?
(Ind
icat
e an
y pa
ram
eter
s tha
t are
mis
sing
from
pro
cess
ing
reco
rds.
)
F6(d
) Rec
ordk
eepi
ng sa
les –
Doe
s the
ope
ratio
n m
aint
ain
sale
s rec
ords
for
each
bat
ch o
f can
nabi
s tha
t inc
lude
at a
min
imum
: (1)
Iden
tity
of th
e va
riety
di
strib
uted
; (2)
Tot
al w
eigh
t of e
ach
varie
ty d
istri
bute
d; (3
) Dat
e of
di
strib
utio
n; a
nd (4
) Ide
ntity
of t
he re
ceiv
ing
oper
atio
n? (I
ndic
ate
any
para
met
ers t
hat a
re m
issi
ng fr
om sa
les r
ecor
ds.)
☐
☐
☐
G7(
a) In
form
atio
n di
sclo
sure
– C
an th
e op
erat
ion
prov
ide
the
follo
win
g re
cord
s upo
n re
ques
t: (1
) Nut
rient
s use
d du
ring
culti
vatio
n; (2
) All
subs
tanc
es
appl
ied
to th
e pl
ant(s
) sur
face
or u
sed
as a
fum
igan
t in
the
culti
vatio
n ar
ea; (
3)
Pest
icid
es a
pplie
d du
ring
culti
vatio
n; a
nd (4
) Oth
er su
bsta
nces
use
d du
ring
culti
vatio
n th
at m
ay re
sult
in a
resi
due
on c
anna
bis?
(Ind
icat
e w
hich
pa
ram
eter
s tha
t can
not b
e pr
ovid
ed, i
f any
.)
☐
☐
☐
G7(
b) In
form
atio
n di
sclo
sure
– Is
info
rmat
ion
prov
ided
by
the
oper
atio
n ab
out t
he id
entit
y, q
ualit
y, a
nd c
ultiv
atio
n co
nditi
ons o
f can
nabi
s acc
urat
e?
☐
☐
☐
G7(
c) In
form
atio
n di
sclo
sure
– D
oes t
he o
pera
tion
disc
lose
the
exte
nt a
nd
type
of t
estin
g an
d an
alys
is c
ondu
cted
on
the
cann
abis
it p
rovi
des?
☐
☐
☐
G7(
c)(1
-3) I
nfor
mat
ion
disc
losu
re –
Doe
s the
dis
clos
ure
cont
ain
the
follo
win
g: (1
) The
type
of t
est,
anal
ysis
, or e
xam
inat
ion
used
, if a
ny, t
o de
term
ine
the
parti
cula
r stra
in o
r cul
tivar
of e
ach
batc
h of
can
nabi
s pro
vide
d;
(2) A
ny te
sts t
o de
term
ine
the
quan
titat
ive
leve
ls o
f con
tain
ed c
onsti
tuen
ts
and,
if so
, the
type
of t
estin
g us
ed; (
3) A
ny te
sts t
o de
term
ine
the
abse
nce
or
pres
ence
of s
peci
fic c
lass
es o
f pot
entia
l con
tam
inan
ts a
nd, i
f so,
the
type
of
test
ing
used
? (I
ndic
ate
whi
ch p
aram
eter
s are
mis
sing
from
the
disc
losu
re.)
☐
☐
☐
G7(
c)(3
)(i-i
ii) In
form
atio
n di
sclo
sure
– D
oes t
he d
iscl
osur
e of
con
tam
inan
t te
stin
g co
ntai
n in
form
atio
n re
gard
ing:
(i) P
estic
ides
; (ii)
Yea
sts a
nd m
olds
; an
d (ii
i) O
ther
mic
robi
olog
ical
con
tam
inan
ts?
(Ind
icat
e w
hich
par
amet
ers a
re
mis
sing
from
the
disc
losu
re re
gard
ing
cont
amin
ant t
estin
g. Is
it c
lear
whi
ch
test
s wer
e co
nduc
ted?
)
☐
☐
☐
SAMPLE
G7(
c)(4
) Inf
orm
atio
n di
sclo
sure
– D
oes t
he o
pera
tion
disc
lose
whe
ther
the
test
ing
was
con
duct
ed b
y th
e cu
ltiva
tion
or p
roce
ssin
g op
erat
ion
or b
y an
ex
tern
al la
bora
tory
?
☐
☐
☐
H8(
a) R
ecal
ls –
Doe
s the
ope
ratio
n ha
ve a
reca
ll pl
an th
at a
ddre
sses
at
min
imum
: (1)
Fac
tors
whi
ch n
eces
sita
te a
reca
ll pr
oced
ure;
(2) P
erso
nnel
re
spon
sible
for a
reca
ll; a
nd (3
) Not
ifica
tion
prot
ocol
s? (I
ndic
ate
whi
ch
para
met
ers a
re m
issi
ng, i
f any
.)
☐
☐
☐
H8(
b) R
ecal
ls –
Doe
s the
ope
ratio
n ha
ve a
est
ablis
hed
polic
y fo
r co
mm
unic
atin
g a
reca
ll of
can
nabi
s tha
t inc
lude
s: (1
) A m
echa
nism
to c
onta
ct
all c
usto
mer
s who
hav
e, o
r cou
ld h
ave,
obt
aine
d th
e ca
nnab
is fr
om th
e cu
ltiva
tion
oper
atio
n or
pro
cess
ing
oper
atio
n; (
2) In
form
atio
n on
the
retu
rn o
r de
stru
ctio
n of
any
reca
lled
prod
uct;
(3) A
mec
hani
sm to
con
tact
the
culti
vatio
n op
erat
ion;
and
(4) C
omm
unic
atio
n an
d ou
treac
h vi
a m
edia
, as n
eces
sary
and
ap
prop
riate
. (In
dica
te a
ny p
aram
eter
s tha
t mis
sing
from
the
reca
ll po
licy.
)
☐
☐
☐
H8(
c) R
ecal
ls –
Doe
s the
reca
ll pl
an in
clud
e di
spos
al o
f rec
alle
d m
ater
ials
in a
m
anne
r tha
t ens
ures
that
they
can
not b
e sa
lvag
ed a
nd w
ill n
ot b
e us
ed b
y a
com
plia
nt in
divi
dual
or a
ny o
ther
per
son?
☐
☐
☐
SAMPLE
A1.
1(a)
• Su
bjec
t ope
ratio
ns –
Exc
ept a
s pro
vide
d by
par
agra
phs (
b), (
c), a
nd
(d) o
f thi
s sec
tion,
any
per
son,
gro
up o
f per
sons
, non
-pro
fit e
ntity
, or b
usin
ess
entit
y is
subj
ect t
o th
is p
art i
f eng
aged
in m
anuf
actu
ring,
pac
kagi
ng, l
abel
ing,
or
hol
ding
ope
ratio
ns fo
r can
nabi
s or c
anna
bis-
der
ived
pro
duct
s in
the
juris
dict
ion
in w
hich
this
par
t app
lies.
☐
☐
☐
A1.
1(b)
• Su
bjec
t ope
ratio
ns –
A c
ompl
iant
indi
vidu
al w
ho m
anuf
actu
res,
pack
s, la
bels
, or h
olds
can
nabi
s or c
anna
bis-
deriv
ed p
rodu
cts i
n ac
cord
ance
w
ith lo
cal a
nd st
ate
law
for p
erso
nal u
se, o
r for
ano
ther
com
plia
nt in
divi
dual
at
no c
harg
e, is
not
subj
ect t
o th
is p
art.
☐
☐
☐
A1.
1(c)
• Su
bjec
t ope
ratio
ns -
Cul
tivat
ion
and
proc
essi
ng o
pera
tions
are
not
su
bjec
t to
this
par
t; ho
wev
er, t
his e
xem
ptio
n do
es n
ot a
pply
to a
ny o
ff-s
ite
war
ehou
se o
r sto
rage
faci
lity
that
serv
es th
e cu
ltiva
tion
or p
roce
ssin
g op
erat
ion.
☐
☐
☐
A1.
1(d)
• Su
bjec
t ope
ratio
ns -
Dis
pens
ing
oper
atio
ns a
re n
ot su
bjec
t to
this
pa
rt; h
owev
er, t
his e
xem
ptio
n do
es n
ot a
pply
to a
ny o
ff-s
ite w
areh
ouse
or
stor
age
faci
lity
that
serv
es th
e di
spen
sing
ope
ratio
n.
☐
☐
☐
SAMPLE
A1.
1(e)
• Su
bjec
t ope
ratio
ns -
Each
ope
ratio
n su
bjec
t to
this
par
t is
resp
onsib
le to
com
ply
with
onl
y th
ose
sect
ions
that
app
ly to
the
activ
ities
co
nduc
ted
by th
at o
pera
tion.
☐
☐
☐
A1.
2 • O
ther
stat
utor
y pr
ovis
ions
and
reg
ulat
ions
– Is
the
man
ufac
turin
g,
pack
agin
g, la
belin
g, a
nd h
oldi
ng o
pera
tion
pres
ently
com
plia
nt w
ith a
ll ot
her
appl
icab
le st
atut
ory
prov
isio
ns a
nd re
gula
tions
rela
ted
to th
ese
oper
atio
ns in
th
e ju
risdi
ctio
n in
whi
ch th
is p
art a
pplie
s, an
d re
late
d to
all
othe
r bus
ines
s ac
tiviti
es u
nder
take
n in
con
duct
ing
thes
e op
erat
ions
?
☐
☐
☐
B2.
1(1-
5) •A
cqui
sitio
n of
can
nabi
s and
can
nabi
s-de
rive
d pr
oduc
ts –
Doe
s th
e op
erat
ion
have
stan
dard
ized
pro
toco
ls, p
roce
dure
s, an
d re
ports
(i.e
., SO
Ps,
wor
k in
stru
ctio
ns, e
tc.)
for t
he a
cqui
sitio
n of
can
nabi
s and
can
nabi
s-de
rived
pr
oduc
ts?
☐
☐
☐
B2.
2(a)
(1-4
) •D
istr
ibut
ion
of c
anna
bis a
nd c
anna
bis-
deri
ved
prod
ucts
–
Doe
s the
ope
ratio
n ha
ve st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts (i
.e.,
SOPs
, wor
k in
stru
ctio
ns, e
tc.)
for t
he d
istri
butio
n of
can
nabi
s and
can
nabi
s-de
rived
pro
duct
s to
lega
l ent
ities
as a
llow
ed in
acc
orda
nce
with
the
juris
dict
ion
of fa
cilit
y?
☐
☐
☐
B2.
2(b)
•Tra
nspo
rtat
ion
of c
anna
bis a
nd c
anna
bis-
deri
ved
prod
ucts
–
Doe
s the
ope
ratio
n ha
ve st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts (i
.e.,
SOPs
, wor
k in
stru
ctio
ns, e
tc.)
for t
he tr
ansp
orta
tion
of c
anna
bis a
nd c
anna
bis-
deriv
ed p
rodu
cts i
n co
mpl
ianc
e w
ith ju
risdi
ctio
n gu
idel
ines
?
☐
☐
☐
B2.
3•A
ncill
ary
oper
atio
ns –
Doe
s the
ope
ratio
n en
gage
in p
erm
itted
anc
illar
y op
erat
ions
oth
er th
an th
e m
anuf
actu
ring,
pac
kagi
ng, l
abel
ing.
or h
oldi
ng o
f ca
nnab
is o
r can
nabi
s-de
rived
pro
duct
s?
☐
☐
☐
C3.
1(a)
(1-3
) • P
erso
nnel
trai
ning
– D
oes t
he m
anuf
actu
ring
oper
atio
n pr
ovid
e tra
inin
g an
d do
cum
enta
tion
show
ing
that
all
pers
onne
l are
trai
ned
to
perfo
rm a
ll as
sign
ed fu
nctio
ns a
nd a
pplic
able
requ
irem
ents
?
☐
☐
☐
SAMPLE
C3.
1(b)
(1) •
Per
sonn
el tr
aini
ng –
Doe
s the
man
ufac
turin
g op
erat
ion
prov
ide
train
ing
and
docu
men
tatio
n of
trai
ning
for p
erso
nnel
in th
e ar
eas o
f reg
ulat
ory
insp
ectio
n pr
epar
edne
ss a
nd la
w-e
nfor
cem
ent i
nter
actio
ns?
☐
☐
☐
C3.
1(b)
(2) P
erso
nnel
trai
ning
– D
oes t
he m
anuf
actu
ring
oper
atio
n pr
ovid
e tra
inin
g an
d th
e do
cum
enta
tion
of tr
aini
ng fo
r per
sonn
el in
the
area
s of U
.S.
fede
ral,
stat
e an
d lo
cal l
aws,
regu
latio
ns, a
nd p
olic
ies r
elat
ing
to th
e m
anuf
actu
ring
activ
ities
of t
he le
gally
ope
ratin
g en
tity?
☐
☐
☐
C3.
2(a)
(1) •
SO
Ps fo
r pe
rson
nel r
espo
nsib
ilitie
s – D
oes t
he m
anuf
actu
ring
oper
atio
n ha
ve st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts fo
r the
ex
clus
ion
from
wor
k of
per
sonn
el w
ho b
y m
edic
al e
xam
inat
ion,
the
pers
on’s
ac
know
ledg
emen
t, or
supe
rvis
ory
obse
rvat
ion,
is sh
own
to h
ave
or a
ppea
rs to
ha
ve a
n ill
ness
, inf
ectio
n, o
pen
lesi
on, o
r any
oth
er a
bnor
mal
sour
ce o
f po
tent
ial m
icro
bial
con
tam
inat
ion
that
cou
ld re
sult
in th
e m
icro
bial
co
ntam
inat
ion
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, ca
nnab
is, c
anna
bis-
deriv
ed p
rodu
cts,
or c
onta
ct su
rface
s, un
til th
e he
alth
co
nditi
on n
o lo
nger
exi
sts?
☐
☐
☐
C3.
2(a)
(2) •
SO
Ps fo
r pe
rson
nel r
espo
nsib
ilitie
s – D
oes t
he m
anuf
actu
ring
oper
atio
n ha
ve st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts in
stru
ctin
g pe
rson
nel t
o no
tify
thei
r sup
ervi
sor(
s) if
they
hav
e or
if th
ere
is a
reas
onab
le
poss
ibili
ty th
at th
ey h
ave
a he
alth
con
ditio
n de
scrib
ed in
C3.
2(a)
(1) t
hat c
ould
re
sult
in m
icro
bial
con
tam
inat
ion
of a
ny c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s, ca
nnab
is-d
eriv
ed p
rodu
cts,
or a
ny c
onta
ct
surfa
ce(s
)?
☐
☐
☐
C3.
2(b)
(1-2
) • S
OPs
for
pers
onne
l hyg
iene
– D
oes t
he m
anuf
actu
ring
oper
atio
n ha
ve st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts th
at in
clud
e th
e w
earin
g of
out
er g
arm
ents
in a
man
ner t
hat p
rote
cts a
gain
st th
e co
ntam
inat
ion
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s, ca
nnab
is-d
eriv
ed p
rodu
cts,
or a
ny c
onta
ct su
rface
and
mai
ntai
ning
ade
quat
e pe
rson
al c
lean
lines
s?
☐
☐
☐
SAMPLE
C3.
2(b)
(3)(
i-iii)
• SO
Ps fo
r pe
rson
nel h
ygie
ne –
Doe
s the
man
ufac
turin
g op
erat
ion
have
stan
dard
ized
pro
toco
ls, p
roce
dure
s, an
d si
gnag
e in
pla
ce
requ
iring
per
sonn
el to
thor
ough
ly w
ash
hand
s with
soap
(and
sani
tizin
g if
nece
ssar
y to
pro
tect
aga
inst
con
tam
inat
ion
with
mic
roor
gani
sms)
bef
ore
star
ting
wor
k, a
fter u
sing
the
rest
room
, and
at a
ny o
ther
tim
e w
hen
thei
r han
ds
may
hav
e be
com
e so
iled
or c
onta
min
ated
?
☐
☐
☐
C3.
2(b)
(4) •
SO
Ps fo
r pe
rson
nel h
ygie
ne –
Doe
s the
man
ufac
turin
g op
erat
ion
have
stan
dard
ized
pro
toco
ls, p
roce
dure
s, an
d re
ports
for t
he re
mov
al o
f all
unse
cure
d je
wel
ry a
nd o
ther
obj
ects
that
mig
ht fa
ll in
to c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
cann
abis
, can
nabi
s-de
rived
pro
duct
s, eq
uipm
ent,
or
pack
agin
g an
d fo
r the
rem
oval
of h
and
jew
elry
that
can
not b
e ad
equa
tely
cl
eane
d du
ring
perio
ds in
whi
ch c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-
proc
ess m
ater
ials
, can
nabi
s, or
can
nabi
s-de
rived
pro
duct
s are
man
ipul
ated
by
hand
? If
han
d je
wel
ry c
anno
t be
rem
oved
, it m
ust b
e co
vere
d by
mat
eria
l tha
t is
mai
ntai
ned
in a
n in
tact
, cle
an, a
nd sa
nita
ry c
ondi
tion
and
that
eff
ectiv
ely
prot
ects
aga
inst
the
cont
amin
atio
n of
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pr
oces
s mat
eria
ls, c
anna
bis,
cann
abis
-der
ived
pro
duct
s, or
con
tact
surfa
ces.
☐
☐
☐
C3.
2(b)
(5) •
SO
Ps fo
r pe
rson
nel h
ygie
ne –
Doe
s the
man
ufac
turin
g op
erat
ion
have
stan
dard
ized
pro
toco
ls a
nd p
roce
dure
s for
the
mai
ntai
ning
of g
love
s use
d in
han
dlin
g co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, ca
nnab
is, o
r can
nabi
s-de
rived
pro
duct
s in
an in
tact
, cle
an, a
nd sa
nita
ry
cond
ition
? G
love
s sho
uld
be o
f an
impe
rmea
ble
mat
eria
l.
☐
☐
☐
C3.
2(b)
(6) •
SO
Ps fo
r pe
rson
nel h
ygie
ne –
Doe
s the
man
ufac
turin
g op
erat
ion
have
stan
dard
ized
pro
toco
ls a
nd p
roce
dure
s for
the
wea
ring,
whe
re
appr
opria
te, o
f hai
r net
s, ca
ps, b
eard
cov
ers,
or o
ther
effe
ctiv
e ha
ir re
stra
ints
?
☐
☐
☐
C3.
2(b)
(7) •
SO
Ps fo
r pe
rson
nel h
ygie
ne –
Doe
s the
man
ufac
turin
g op
erat
ion
have
stan
dard
ized
pro
toco
ls a
nd p
roce
dure
s for
the
stor
age
of
clot
hing
or o
ther
per
sona
l bel
ongi
ngs i
n ar
eas w
here
it c
anno
t com
e in
to
cont
act w
ith o
r pot
entia
lly c
onta
min
ate
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
mat
eria
ls, c
anna
bis,
or c
anna
bis-
deriv
ed p
rodu
cts ?
☐
☐
☐
SAMPLE
C3.
2(b)
(8) •
SO
Ps fo
r pe
rson
nel h
ygie
ne –
Doe
s the
man
ufac
turin
g op
erat
ion
have
stan
dard
ized
pro
toco
ls a
nd p
roce
dure
s in
plac
e re
stric
ting
staf
f fro
m e
atin
g fo
od, c
hew
ing
gum
, drin
king
bev
erag
es, o
r usi
ng to
bacc
o pr
oduc
ts
whe
re c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s, or
ca
nnab
is-d
eriv
ed p
rodu
cts o
r any
con
tact
surfa
ces a
re e
xpos
ed o
r whe
re
cont
act s
urfa
ces a
re w
ashe
d?
☐
☐
☐
C3.
2(b)
(9) •
SO
Ps fo
r pe
rson
nel h
ygie
ne –
Doe
s the
man
ufac
turin
g op
erat
ion
have
stan
dard
ized
pro
toco
ls, p
roce
dure
s, an
d re
ports
in p
lace
ne
cess
ary
to p
rote
ct a
gain
st th
e co
ntam
inat
ion
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s, or
can
nabi
s-de
rived
pro
duct
s, or
an
y co
ntac
t sur
face
s with
mic
roor
gani
sms,
filth
, or a
ny o
ther
ext
rane
ous
mat
eria
ls, i
nclu
ding
per
spira
tion,
hai
r, co
smet
ics,
toba
cco,
che
mic
als,
and
med
icin
es a
pplie
d to
the
skin
?
☐
☐
☐
C3.
2(b)
(10)
• SO
Ps fo
r pe
rson
nel h
ygie
ne –
Doe
s the
man
ufac
turin
g op
erat
ion
have
stan
dard
ized
pro
toco
ls, p
roce
dure
s, an
d re
ports
in p
lace
ne
cess
ary
to m
aint
ain
the
secu
rity
of th
e ph
ysic
al p
lant
, to
prev
ent
unau
thor
ized
acc
ess t
o co
ntro
lled
acce
ss a
reas
, and
to m
aint
ain
stric
t con
trol o
f in
-pro
cess
mat
eria
ls, c
anna
bis,
cann
abis
-der
ived
pro
duct
s, an
d ca
nnab
is w
aste
?
☐
☐
☐
C3.
2(b)
(11)
• SO
Ps fo
r pe
rson
nel h
ygie
ne –
Doe
s the
man
ufac
turin
g op
erat
ion
have
stan
dard
ized
pro
toco
ls, p
roce
dure
s, an
d re
ports
in p
lace
ne
cess
ary
to c
ontro
l acc
ess t
o ar
eas o
nly
as a
utho
rized
by
supe
rvis
ory
pers
onne
l?
☐
☐
☐
C3.
3(a)
(1-2
) • P
erso
nnel
safe
ty –
Doe
s the
ope
ratio
n ha
ve p
olic
ies,
proc
edur
es, a
nd e
vide
nce
of a
dequ
ate
safe
ty tr
aini
ng fo
r per
sonn
el to
com
ply
with
per
sonn
el sa
fety
pol
icie
s, in
clud
ing
pers
onne
l acc
iden
t rep
ortin
g an
d in
vest
igat
ion
polic
ies,
as w
ell a
s fire
pre
vent
ion
and
resp
onse
pla
ns?
☐
☐
☐
C3.
3(a)
(3-4
) • P
erso
nnel
safe
ty –
Doe
s the
ope
ratio
n ha
ve p
olic
ies,
proc
edur
es, a
nd e
vide
nce
of a
dequ
ate
safe
ty tr
aini
ng fo
r per
sonn
el to
com
ply
with
requ
ired
mat
eria
ls h
andl
ing
and
haza
rd c
omm
unic
atio
ns p
olic
ies,
incl
udin
g m
aint
enan
ce o
f mat
eria
l saf
ety
data
shee
ts (M
SDS)
and
per
sona
l pr
otec
tive
equi
pmen
t pol
icie
s?
☐
☐
☐
C3.
3(b)
(1-5
) • P
erso
nnel
safe
ty –
Doe
s the
ope
ratio
n ha
ve a
n em
erge
ncy
cont
act l
ist v
isib
ly p
oste
d an
d m
aint
aine
d th
at in
clud
es c
onta
ct in
form
atio
n fo
r th
e op
erat
ion
man
ager
(s),
emer
genc
y re
spon
ders
, poi
son
cont
rol,
loca
l fire
de
partm
ent,
and
spill
resp
onse
team
(s)?
☐
☐
☐
SAMPLE
C3.
3(c)
• Pe
rson
nel s
afet
y– D
oes t
he o
pera
tion
have
evi
denc
e th
at it
ope
rate
s in
adh
eren
ce w
ith a
ll ap
plic
able
stan
dard
s of t
he fe
dera
l Occ
upat
iona
l Hea
lth
and
Safe
ty A
dmin
istra
tion,
as w
ell a
s any
app
licab
le st
ate
or lo
cal w
orke
r sa
fety
requ
irem
ents
?
☐
☐
☐
C3.
4(a-
b) •
Supe
rvis
or r
equi
rem
ents
– D
oes t
he o
pera
tion
have
evi
denc
e th
at e
ach
supe
rvis
or re
spon
sible
for t
he m
anuf
actu
ring,
pac
kagi
ng, l
abel
ing,
an
d ho
ldin
g of
can
nabi
s and
can
nabi
s-de
rived
pro
duct
s has
rece
ived
eith
er
adeq
uate
edu
catio
n, tr
aini
ng, a
nd e
xper
ienc
e, o
r any
com
bina
tion
ther
eof,
to
perfo
rm a
ssig
ned
func
tions
in su
ch a
man
ner a
s to
prov
ide
assu
ranc
e th
at th
e ca
nnab
is o
r can
nabi
s-de
rived
pro
duct
s has
the
iden
tity,
pur
ity, s
treng
th, a
nd
com
posi
tion
that
it p
urpo
rts o
r is r
epre
sent
ed to
pos
sess
?
☐
☐
☐
C3.
4(c)
• Su
perv
isor
req
uire
men
ts –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
on
e or
mor
e su
perv
isor
s qua
lifie
d by
edu
catio
n, tr
aini
ng, o
r exp
erie
nce
are
assi
gned
to su
perv
ise
and
deve
lop
sani
tatio
n pr
oced
ures
? ☐
☐
☐
D4.
1(a)
• D
esig
n an
d co
nstr
uctio
n –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
th
e ph
ysic
al p
lant
use
d in
the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, o
r hol
ding
of
can
nabi
s or c
anna
bis-
deriv
ed p
rodu
cts i
s of s
uita
ble
size
, con
stru
ctio
n an
d de
sign
to fa
cilit
ate
mai
nten
ance
, cle
anin
g an
d/or
sani
tizin
g, a
s app
licab
le to
the
oper
atio
n?
☐
☐
☐
D4.
1(b)
• D
esig
n an
d co
nstr
uctio
n –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
th
e ph
ysic
al p
lant
is d
esig
ned
in a
man
ner t
hat p
rovi
des a
dequ
ate
spac
e fo
r the
or
derly
pla
cem
ent o
f equ
ipm
ent a
nd m
ater
ials
to p
reve
nt m
ix-u
ps o
f co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s, or
ca
nnab
is-d
eriv
ed p
rodu
cts d
urin
g m
anuf
actu
ring,
pac
kagi
ng, l
abel
ing,
or
hold
ing?
☐
☐
☐
D4.
1(c)
(1) •
Des
ign
and
cons
truc
tion
– D
oes t
he o
pera
tion
have
evi
denc
e th
at
the
phys
ical
pla
nt w
as d
esig
ned
and
cons
truct
ed in
a m
anne
r tha
t red
uces
the
pote
ntia
l for
con
tam
inat
ion
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
cann
abis
, ca
nnab
is-d
eriv
ed p
rodu
cts,
or c
onta
ct su
rface
s w
ith m
icro
orga
nism
s, ch
emic
als,
filth
, or o
ther
ext
rane
ous m
ater
ial,
incl
udin
g th
e co
nstru
ctio
n of
flo
ors,
wal
ls, a
nd c
eilin
gs th
at c
an b
e ad
equa
tely
cle
aned
, kep
t cle
an, a
nd in
go
od re
pair.
☐
☐
☐
SAMPLE
D4.
1(c)
(2) •
Des
ign
and
cons
truc
tion
– D
oes t
he o
pera
tion
have
evi
denc
e th
at
the
phys
ical
pla
nt w
as d
esig
ned
and
cons
truct
ed u
sing
fixtu
res,
duct
s, an
d pi
pes t
hat d
o no
t con
tam
inat
e co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss
mat
eria
ls, c
anna
bis,
or c
anna
bis-
deriv
ed p
rodu
cts o
r con
tact
surfa
ces b
y dr
ippi
ng, o
ther
leak
age,
or c
onde
nsat
ion?
☐
☐
☐
D4.
1(c)
(3) •
Des
ign
and
cons
truc
tion
– Is
the
phys
ical
pla
nt w
as d
esig
ned
and
cons
truct
ed in
such
a m
anne
r as t
o pr
ovid
e ai
sles
or w
orki
ng sp
aces
be
twee
n eq
uipm
ent a
nd w
alls
that
are
ade
quat
ely
unob
stru
cted
and
of a
dequ
ate
wid
th to
per
mit
all p
erso
ns to
per
form
thei
r dut
ies a
nd to
pro
tect
aga
inst
co
ntam
inat
ion
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, ca
nnab
is o
r can
nabi
s-de
rived
pro
duct
s, or
con
tact
surfa
ces w
ith c
loth
ing
or
pers
onal
con
tact
?
☐
☐
☐
D4.
1(c)
(4) •
Des
ign
and
cons
truc
tion
– D
oes t
he o
pera
tion
have
evi
denc
e th
at
the
phys
ical
pla
nt w
as d
esig
ned
and
cons
truct
ed u
sing
safe
ty-ty
pe li
ght b
ulbs
, fix
ture
s, sk
ylig
hts,
or o
ther
gla
ss o
r gla
ss-li
ke m
ater
ials
in a
ll ar
eas t
hat a
re
susp
ende
d ov
er e
xpos
ed c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss
mat
eria
ls, o
r can
nabi
s or c
anna
bis-
deriv
ed p
rodu
cts?
Is t
he p
hysi
cal p
lant
is
othe
rwis
e co
nstru
cted
in a
man
ner t
hat w
ill p
rote
ct a
gain
st c
onta
min
atio
n of
co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, or c
anna
bis o
r ca
nnab
is-d
eriv
ed p
rodu
cts i
n ca
se o
f bre
akag
e of
ove
rhea
d gl
ass o
r gla
ss-li
ke
mat
eria
ls?
☐
☐
☐
D4.
1(d)
• D
esig
n an
d co
nstr
uctio
n –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
th
e ph
ysic
al p
lant
was
des
igne
d an
d co
nstru
cted
in su
ch a
man
ner a
s to
prov
ide
sepa
rate
or d
efin
ed a
reas
, or o
ther
con
trol s
yste
ms s
uch
as c
ompu
teriz
ed
inve
ntor
y co
ntro
ls o
r aut
omat
ed sy
stem
s of s
epar
atio
n, to
pre
vent
cro
ss-
cont
amin
atio
n an
d m
ix-u
ps o
f com
pone
nts,
cann
abis
, or c
anna
bis-
deriv
ed
prod
ucts
dur
ing
the
follo
win
g op
erat
ions
that
mig
ht ta
ke p
lace
in th
e ph
ysic
al
plan
t:
☐
☐
☐
(1) R
ecei
pt, i
dent
ifica
tion,
stor
age,
and
with
hold
ing
from
use
of q
uara
ntin
ed
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
mat
eria
ls, c
anna
bis,
or
cann
abis
-der
ived
pro
duct
pen
ding
dis
posi
tion
by q
ualit
y-co
ntro
l per
sonn
el;
☐
☐
☐
(2) S
tora
ge o
f app
rove
d co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss
mat
eria
ls, c
anna
bis,
or c
anna
bis-
deriv
ed p
rodu
cts;
☐
☐
☐
SAMPLE
(3) S
tora
ge o
f rej
ecte
d co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss
mat
eria
ls, c
anna
bis,
or c
anna
bis-
deriv
ed p
rodu
cts,
and
cann
abis
was
te p
endi
ng
retu
rn to
thei
r sup
plie
r or d
estru
ctio
n;
☐
☐
☐
(4) S
tora
ge o
f in-
proc
ess m
ater
ials
pen
ding
nor
mal
furth
er p
roce
ssin
g;
☐
☐
☐
(5) S
tora
ge o
f com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
mat
eria
ls, a
nd
prod
ucts
pen
ding
repr
oces
sing
; ☐
☐
☐
(6) M
anuf
actu
ring
oper
atio
ns;
☐
☐
☐
(7) P
acka
ging
and
labe
ling
oper
atio
ns;
☐
☐
☐
(8) S
epar
atio
n of
the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, a
nd h
oldi
ng o
f di
ffere
nt p
rodu
ct ty
pes i
nclu
ding
diff
eren
t typ
es o
f can
nabi
s or c
anna
bis-
deriv
ed p
rodu
cts a
nd o
ther
pro
duct
s han
dled
in th
e sa
me
phys
ical
pla
nt;
☐
☐
☐
(9) P
erfo
rman
ce o
f lab
orat
ory
anal
yses
and
stor
age
of la
bora
tory
supp
lies a
nd
sam
ples
, as a
pplic
able
; ☐
☐
☐
(10)
Cle
anin
g an
d sa
nita
tion
of c
onta
ct su
rface
s.
☐
☐
☐
D4.
1(e)
(1) •
Des
ign
and
cons
truc
tion/
wat
er –
Doe
s the
ope
ratio
n ha
ve
evid
ence
that
the
wat
er p
rovi
ded
is sa
fe a
nd sa
nita
ry, a
t sui
tabl
e te
mpe
ratu
res,
and
unde
r pre
ssur
e as
nee
ded,
for a
ll us
es w
here
wat
er d
oes n
ot b
ecom
e a
com
pone
nt o
f the
can
nabi
s-de
rived
pro
duct
?
☐
☐
☐
SAMPLE
D4.
1(e)
(2) •
Des
ign
and
cons
truc
tion/
wat
er –
Doe
s the
ope
ratio
n ha
ve
evid
ence
that
the
wat
er p
rovi
ded
is co
mpl
iant
with
app
licab
le st
ate
and
loca
l po
tabl
e w
ater
requ
irem
ents
and
with
oth
er re
quire
men
ts a
s nec
essa
ry to
ens
ure
the
wat
er re
quire
men
ts a
nd w
ith o
ther
requ
irem
ents
as n
eces
sary
to e
nsur
e th
e w
ater
doe
s not
con
tam
inat
e th
e ca
nnab
is-d
eriv
ed p
rodu
ct, f
or a
ll us
es w
here
su
ch w
ater
may
bec
ome
a co
mpo
nent
of t
he c
anna
bis-
deriv
ed p
rodu
ct, e
.g.,
whe
n su
ch w
ater
con
tact
s com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
m
ater
ials
, can
nabi
s or c
anna
bis-
deriv
ed p
rodu
cts,
or a
ny c
onta
ct su
rface
?
☐
☐
☐
D4.
1(f)
• D
esig
n an
d co
nstr
uctio
n/ve
ntila
tion
– D
oes t
he o
pera
tion
have
ev
iden
ce th
at th
e he
atin
g, v
entil
atio
n, c
oolin
g, a
nd a
ir fil
tratio
n ha
s bee
n in
stal
led
and
mai
ntai
ned
in th
e ph
ysic
al p
lant
as n
eede
d to
ens
ure
the
qual
ity o
f th
e pr
oduc
t?
☐
☐
☐
D4.
1(f)
(1) •
Des
ign
and
cons
truc
tion/
vent
ilatio
n –
Doe
s the
ope
ratio
n ha
ve
SOPs
, pro
cedu
res,
and
mai
nten
ance
repo
rts fo
r all
vent
ilatio
n eq
uipm
ent s
uch
as fi
lters
, fan
s, ex
haus
ts, d
ust c
olle
ctio
ns, a
nd o
ther
air-
blow
ing
equi
pmen
t as
requ
ired
in a
ll ar
eas w
here
odo
rs, d
ust,
and
vapo
rs (i
nclu
ding
stea
m a
nd
noxi
ous f
umes
) tha
t may
con
tam
inat
e co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-
proc
ess m
ater
ials
, can
nabi
s or c
anna
bis-
deriv
ed p
rodu
cts,
or c
onta
ct su
rface
s?
☐
☐
☐
D4.
1(f)
(2) •
Des
ign
and
cons
truc
tion/
vent
ilatio
n –
Doe
s the
ope
ratio
n ha
ve
evid
ence
that
whe
n fa
ns, c
ompr
esse
d ai
r, or
oth
er a
ir-bl
owin
g eq
uipm
ent i
s us
ed, s
uch
equi
pmen
ts is
des
igne
d, lo
cate
d, a
nd o
pera
ted
in a
man
ner t
hat
min
imiz
es th
e po
tent
ial f
or m
icro
orga
nism
s and
par
ticul
ate
mat
ter t
o co
ntam
inat
e co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, ca
nnab
is, c
anna
bis-
deriv
ed p
rodu
cts,
or c
onta
ct su
rface
s?
☐
☐
☐
D4.
1(f)
(2) •
Des
ign
and
cons
truc
tion/
vent
ilatio
n –
Doe
s the
ope
ratio
n ha
ve
evid
ence
that
the
equi
pmen
t use
d to
con
trol t
empe
ratu
re, h
umid
ity, a
nd/o
r m
icro
orga
nism
s is p
rovi
ded
and
mai
ntai
ned
as n
eces
sary
to e
nsur
e th
e qu
ality
of
the
prod
uct?
☐
☐
☐
D4.
1(g)
(1-2
) • D
esig
n an
d co
nstr
uctio
n/pl
umbi
ng –
Doe
s the
ope
ratio
n ha
ve
evid
ence
that
the
plum
bing
in th
e ph
ysic
al p
lant
is o
f an
adeq
uate
size
and
de
sign
and
has
bee
n ad
equa
tely
inst
alle
d an
d m
aint
aine
d to
bot
h ca
rry
suffi
cien
t am
ount
s of w
ater
to re
quire
d lo
catio
ns th
roug
hout
the
plan
t and
pr
oper
ly c
onve
y se
wag
e an
d liq
uid
disp
osab
le w
aste
from
the
phys
ical
pla
nt?
☐
☐
☐
SAMPLE
D4.
1(g)
(3) •
Des
ign
and
cons
truc
tion/
plum
bing
– D
oes t
he o
pera
tion
have
ev
iden
ce th
at th
e pl
umbi
ng in
the
phys
ical
pla
nt is
of a
n ad
equa
te si
ze a
nd
desi
gn a
nd h
as b
een
adeq
uate
ly in
stal
led
and
mai
ntai
ned
to a
void
bei
ng a
so
urce
of c
onta
min
atio
n to
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
m
ater
ials
, can
nabi
s or c
anna
bis-
deriv
ed p
rodu
cts,
wat
er su
pplie
s, or
any
co
ntac
t sur
face
, or c
reat
ing
an u
nsan
itary
con
ditio
n?
☐
☐
☐
D4.
1(g)
(4) •
Des
ign
and
cons
truc
tion/
plum
bing
– D
oes t
he o
pera
tion
have
ev
iden
ce th
at th
e pl
umbi
ng in
the
phys
ical
pla
nt is
of a
n ad
equa
te si
ze a
nd
desi
gn a
nd h
as b
een
adeq
uate
ly in
stal
led
and
mai
ntai
ned
to p
rovi
de a
dequ
ate
floor
dra
inag
e in
all
area
s whe
re fl
oors
are
subj
ect t
o flo
odin
g-ty
pe c
lean
ing
or
whe
re n
orm
al o
pera
tions
rele
ase
or d
isch
arge
wat
er o
r oth
er li
quid
was
te o
n th
e flo
or?
☐
☐
☐
D4.
1(g)
(5) •
Des
ign
and
cons
truc
tion/
plum
bing
– D
oes t
he o
pera
tion
have
ev
iden
ce th
at th
e pl
umbi
ng in
the
phys
ical
pla
nt is
of a
n ad
equa
te si
ze a
nd
desi
gn a
nd h
as b
een
adeq
uate
ly in
stal
led
and
mai
ntai
ned
to n
o al
low
bac
kflo
w
from
, or c
ross
con
nect
ion
betw
een,
pip
ing
syst
ems t
hat d
isch
arge
was
te w
ater
or
sew
age
and
pipi
ng sy
stem
s tha
t car
ry w
ater
use
d fo
r man
ufac
turin
g ca
nnab
is-d
eriv
ed p
rodu
cts,
for c
lean
ing
cont
act s
urfa
ces,
or fo
r use
in
bath
room
s or h
and-
was
hing
faci
litie
s?
☐
☐
☐
D4.
1(h)
(1-3
) • D
esig
n an
d co
nstr
uctio
n/pl
umbi
ng –
Doe
s the
ope
ratio
n ha
ve
evid
ence
that
per
sonn
el h
as b
een
prov
ided
with
ade
quat
e, re
adily
acc
essi
ble
toile
t fac
ilitie
s tha
t are
mai
ntai
ned
in a
cle
an a
nd sa
nita
ry c
ondi
tion,
ade
quat
ely
stoc
ked
with
toile
t pap
er, s
oap,
and
sin
gle-
use
pape
r tow
els o
r oth
er d
ryin
g de
vice
s, an
d ke
pt in
goo
d re
pair
at a
ll tim
es?
☐
☐
☐
D4.
1(h)
(1-3
) • D
esig
n an
d co
nstr
uctio
n/pl
umbi
ng –
Doe
s the
ope
ratio
n ha
ve
evid
ence
that
per
sonn
el h
as b
een
prov
ided
with
ade
quat
e, re
adily
acc
essi
ble
toile
t fac
ilitie
s tha
t are
equ
ippe
d w
ith s
igna
ge a
dvis
ing
pers
onne
l of t
he
nece
ssity
of w
ashi
ng h
ands
prio
r to
retu
rnin
g to
wor
k?
☐
☐
☐
D4.
1(h)
(5) •
Des
ign
and
cons
truc
tion/
toile
t fac
ility
– D
oes t
he o
pera
tion
have
evi
denc
e th
at th
e to
ilet f
acili
ties a
re p
rohi
bite
d fro
m b
eing
use
d fo
r ac
tiviti
es th
at su
ppor
t pro
duct
ion
oper
atio
ns, s
uch
as c
lean
ing
of p
rodu
ctio
n eq
uipm
ent o
r ute
nsils
?
☐
☐
☐
SAMPLE
D4.
1(i)
• Des
ign
and
cons
truc
tion/
toile
t fac
ility
– D
oes t
he o
pera
tion
have
ev
iden
ce th
at it
has
take
n ac
tion
to p
reve
nt a
irbor
ne c
onta
min
atio
n fro
m to
ilet
faci
litie
s fro
m c
onta
ctin
g co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss
mat
eria
ls, c
anna
bis,
cann
abis
-der
ived
pro
duct
s, or
con
tact
s sou
rces
; for
ex
ampl
e, b
y pr
ovid
ing
adeq
uate
phy
sica
l sep
arat
ion
of to
ilet f
acili
ties f
rom
m
anuf
actu
ring,
pac
kagi
ng, l
abel
ing,
and
hol
ding
ope
ratio
ns, o
r by
use
of
nega
tive
air p
ress
ure
with
in th
e to
ilet f
acili
ty?
☐
☐
☐
D4.
1(j)
(1-3
) • D
esig
n an
d co
nstr
uctio
n/ha
nd w
ashi
ng –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
it h
as p
rovi
ded
adeq
uate
and
con
veni
ent h
and-
was
hing
fa
cilit
ies t
hat p
rovi
de ru
nnin
g w
ater
of s
uita
ble
tem
pera
ture
, effe
ctiv
e ha
nd
clea
ning
and
/or s
aniti
zing
pre
para
tions
and
sin
gle-
use
pape
r tow
els o
r oth
er
dryi
ng d
evic
es, a
nd th
at a
re lo
cate
d at
poi
nts i
n th
e fa
cilit
y w
here
goo
d sa
nita
ry p
ract
ices
as r
equi
red
for p
erso
nnel
to w
ash
thei
r han
ds?
☐
☐
☐
D4.
1(j)
(4) •
Des
ign
and
cons
truc
tion/
hand
was
hing
– D
oes t
he o
pera
tion
have
evi
denc
e th
at it
has
SO
Ps p
rohi
bitin
g ha
nd-w
ashi
ng fa
cilit
ies f
rom
bei
ng
used
for a
ctiv
ities
that
supp
ort p
rodu
ctio
n op
erat
ions
, suc
h as
cle
anin
g of
pr
oduc
tion
equi
pmen
t or u
tens
ils ?
☐
☐
☐
D4.
1(k)
(1-3
) • D
esig
n an
d co
nstr
uctio
n/lig
htin
g –
Doe
s the
ope
ratio
n ha
ve
evid
ence
that
ade
quat
e lig
htin
g is
pro
vide
d in
all
area
s whe
re c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s, or
can
nabi
s-de
rived
pr
oduc
ts a
re e
xam
ined
, man
ufac
ture
d, p
acka
ged,
labe
led,
or h
eld,
as w
ell a
s w
here
con
tact
surfa
ces a
re c
lean
ed, i
n ha
nd-w
ashi
ng a
reas
, dre
ssin
g an
d lo
cker
ro
oms,
and
toile
t fac
ilitie
s?
☐
☐
☐
D4.
2(a)
(1) •
San
itatio
n re
quir
emen
ts -
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
th
e gr
ound
s of t
he p
hysi
cal p
lant
are
kep
t in
a co
nditi
on th
at p
rote
cts a
gain
st
cont
amin
atio
n of
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
mat
eria
ls,
cann
abis
, can
nabi
s-de
rived
pro
duct
s, or
con
tact
surfa
ces b
y pr
oper
ly st
orin
g eq
uipm
ent,
rem
ovin
g lit
ter a
nd w
aste
, and
cut
ting
wee
ds o
r gra
ss w
ithin
the
imm
edia
te v
icin
ity o
f the
phy
sica
l pla
nt so
that
it d
oes n
ot a
ttrac
t pes
ts, h
arbo
r pe
sts,
or p
rovi
de p
ests
a p
lace
for b
reed
ing?
☐
☐
☐
SAMPLE
D4.
2(a)
(2) •
San
itatio
n re
quir
emen
ts -
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
th
e gr
ound
s of t
he p
hysi
cal p
lant
are
kep
t in
a co
nditi
on th
at p
rote
cts a
gain
st
cont
amin
atio
n of
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
mat
eria
ls,
cann
abis
, can
nabi
s-de
rived
pro
duct
s, or
con
tact
surfa
ces b
y pr
oper
ly
mai
ntai
ning
road
s, ya
rds,
and
park
ing
lots
so th
at th
ey d
o no
t con
stitu
te a
so
urce
of c
onta
min
atio
n in
are
as w
here
com
pone
nts,
in-p
roce
ss m
ater
ials
, ca
nnab
is, c
anna
bis-
deriv
ed p
rodu
cts,
or c
onta
ct su
rface
s are
exp
osed
?
☐
☐
☐
D4.
2(a)
(3) •
San
itatio
n re
quir
emen
ts -
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
th
e gr
ound
s of t
he p
hysi
cal p
lant
are
kep
t in
a co
nditi
on th
at p
rovi
des
adeq
uate
ly d
rain
age
of a
reas
that
may
con
tribu
te to
the
cont
amin
atio
n of
co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s, ca
nnab
is-
deriv
ed p
rodu
cts,
or c
onta
ct su
rface
s by
seep
age,
filth
, or a
ny o
ther
ext
rane
ous
mat
eria
ls, o
r by
prov
idin
g a
bree
ding
pla
ce fo
r pes
ts?
☐
☐
☐
D4.
2(a)
(4) •
San
itatio
n re
quir
emen
ts -
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
th
e gr
ound
s of t
he p
hysi
cal p
lant
are
kep
t in
a co
nditi
on th
at p
rovi
des
adeq
uate
ly o
pera
ting
syst
ems f
or w
aste
trea
tmen
t and
dis
posa
l so
that
they
do
not c
onst
itute
a so
urce
of c
onta
min
atio
n in
are
as w
here
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
mat
eria
ls, c
anna
bis,
cann
abis
-der
ived
pro
duct
s, or
co
ntac
t sur
face
s are
exp
osed
?
☐
☐
☐
D4.
2(a)
(5) •
San
itatio
n re
quir
emen
ts -
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
if
the
grou
nds o
f the
phy
sica
l pla
nt a
re b
orde
red
by g
roun
ds n
ot u
nder
the
oper
atio
n’s c
ontro
l, an
d if
thos
e ot
her g
roun
ds a
re n
ot m
aint
aine
d n
the
man
ner
desc
ribed
in th
is se
ctio
n, c
are
has b
een
exer
cise
d in
the
plan
t by
insp
ectio
n,
exte
rmin
atio
n, o
r oth
er m
eans
to e
xclu
de p
ests
, dirt
, and
filth
or a
ny o
ther
ex
trane
ous m
ater
ials
that
may
be
a so
urce
of c
onta
min
atio
n?
☐
☐
☐
D4.
2(b)
• Sa
nita
tion
requ
irem
ents
– D
oes t
he o
pera
tion
have
evi
denc
e th
at
the
phys
ical
pla
nt is
mai
ntai
ned
in a
cle
an a
nd sa
nita
ry c
ondi
tion
and
mai
ntai
ned
in su
ffici
ent r
epai
r to
prev
ent c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s, ca
nnab
is-d
eriv
ed p
rodu
cts,
or c
onta
ct su
rface
s fro
m b
ecom
ing
cont
amin
ated
?
☐
☐
☐
D4.
2(c)
(1) •
San
itatio
n re
quir
emen
ts –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
th
e ph
ysic
al p
lant
has
SO
Ps, p
roce
dure
s, an
d re
cord
s in
plac
e fo
r the
pro
per
stor
age,
han
dlin
g, a
nd c
ontro
l of c
lean
ing
com
poun
ds, s
aniti
zing
age
nts,
pest
icid
es, a
nd o
ther
toxi
c m
ater
ials
so a
s to
keep
the
prod
ucts
free
from
m
icro
orga
nism
s of p
ublic
hea
lth si
gnifi
canc
e?
☐
☐
☐
SAMPLE
D4.
2(c)
(2)(i
-iv) •
San
itatio
n re
quir
emen
ts –
Doe
s the
ope
ratio
n ha
ve
evid
ence
that
toxi
c m
ater
ials
are
not
use
d or
hel
d in
a p
hysi
cal p
lant
in w
hich
co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s, ca
nnab
is-
deriv
ed p
rodu
cts,
or c
onta
ct su
rface
s are
man
ufac
ture
d or
exp
osed
, unl
ess
thos
e m
ater
ials
are
nec
essa
ry to
mai
ntai
n cl
ean
and
sani
tary
con
ditio
ns, f
or u
se
in la
bora
tory
test
ing
proc
edur
es, f
or m
aint
aini
ng o
r ope
ratin
g th
e ph
ysic
al
plan
t or e
quip
men
t, or
for t
he u
se in
the
plan
t’s o
pera
tions
?
☐
☐
☐
D4.
2(c)
(3) •
San
itatio
n re
quir
emen
ts –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
al
l cle
anin
g co
mpo
unds
, san
itizi
ng a
gent
s, pe
stic
ides
, pes
ticid
e ch
emic
als,
and
othe
r tox
ic m
ater
ials
are
pro
perly
iden
tifie
d, st
ored
, and
use
d in
a m
anne
r tha
t pr
otec
ts a
gain
st c
onta
min
atio
n of
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pr
oces
s mat
eria
ls, c
anna
bis,
cann
abis
-der
ived
pro
duct
s, or
con
tact
surfa
ces?
☐
☐
☐
D4.
2(d)
(1) •
San
itatio
n re
quir
emen
ts –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce p
rovi
ding
ade
quat
e pe
st c
ontro
l pr
ohib
iting
ani
mal
s or p
ests
in a
reas
of t
he p
hysi
cal p
lant
? (G
uard
dog
s may
be
allo
wed
in so
me
area
s of t
he p
hysi
cal p
lant
if th
eir p
rese
nce
will
not
resu
lt in
co
ntam
inat
ion
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, ca
nnab
is o
r can
nabi
s-de
rived
pro
duct
s, or
con
tact
surfa
ces.)
☐
☐
☐
D4.
2(d)
(2) •
San
itatio
n re
quir
emen
ts –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
effe
ctiv
e m
easu
res h
ave
been
take
n to
exc
lude
pes
ts fr
om th
e ph
ysic
al
plan
t and
to p
rote
ct a
gain
st c
onta
min
atio
n of
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
mat
eria
ls, c
anna
bis o
r can
nabi
s-de
rived
pro
duct
s, an
d co
ntac
t sur
face
s on
the
prem
ises
by
pest
s?
☐
☐
☐
D4.
2(d)
(3) •
San
itatio
n re
quir
emen
ts –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce sh
owin
g th
at in
sect
icid
es, f
ungi
cide
s, an
d ro
dent
icid
es a
re n
ot u
sed
in o
r aro
und
the
phys
ical
pla
nt, u
nles
s the
y ar
e re
gist
ered
with
the
EPA
and
use
d in
acc
orda
nce
with
the
labe
l ins
truct
ions
, and
ef
fect
ive
prec
autio
ns a
re ta
ken
to p
rote
ct a
gain
st th
e co
ntam
inat
ion
of
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
mat
eria
ls, c
anna
bis o
r ca
nnab
is-d
eriv
ed p
rodu
cts,
or c
onta
ct su
rface
s?
☐
☐
☐
SAMPLE
D4.
2(e)
(1-3
) • S
anita
tion
requ
irem
ents
– D
oes t
he o
pera
tion
have
evi
denc
e th
at tr
ash
is re
gula
rly c
onve
yed,
stor
ed, a
nd d
ispo
sed
of in
ord
er to
min
imiz
e th
e de
velo
pmen
t of o
dors
, min
imiz
e th
e po
tent
ial t
o at
tract
, har
bor,
or b
ecom
e a
bree
ding
pla
ce fo
r pes
ts, p
rote
ct a
gain
st th
e co
ntam
inat
ion
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ial,
cann
abis
, can
nabi
s-de
rived
pr
oduc
ts, a
ny c
onta
ct su
rface
s, w
ater
supp
lies,
and
grou
nds s
urro
undi
ng th
e ph
ysic
al p
lant
?
☐
☐
☐
D4.
2(e)
(4) •
San
itatio
n re
quir
emen
ts –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
tra
sh is
regu
larly
con
veye
d, st
ored
, and
dis
pose
d of
in o
rder
to c
ontro
l ha
zard
ous w
aste
to p
reve
nt th
e co
ntam
inat
ion
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ial,
cann
abis
, can
nabi
s-de
rived
pro
duct
s, an
y co
ntac
t sur
face
s?
☐
☐
☐
D4.
2(f)
(1-3
) • S
anita
tion
requ
irem
ents
– D
oes t
he m
anuf
actu
ring,
pac
kagi
ng,
labe
ling,
or h
oldi
ng o
pera
tion(
s) h
ave
SOPs
, pro
cedu
res,
and
reco
rd k
eepi
ng in
pl
ace
addr
essi
ng th
e re
spon
sibili
ty fo
r and
des
crip
tion
of th
e cl
eani
ng
sche
dule
s, m
etho
ds, e
quip
men
t, an
d m
ater
ials
to b
e us
ed in
cle
anin
g th
e gr
ound
s and
bui
ldin
gs?
☐
☐
☐
D4.
2(g)
(1-2
) • S
anita
tion
requ
irem
ents
– D
oes t
he m
anuf
actu
ring,
pa
ckag
ing,
labe
ling,
or h
oldi
ng o
pera
tion(
s) h
ave
SOPs
, pro
cedu
res,
and
reco
rd k
eepi
ng in
pla
ce fo
r use
and
stor
age
of ro
dent
icid
es, i
nsec
ticid
es,
fung
icid
es, f
umig
atin
g ag
ents
, and
cle
anin
g an
d sa
nitiz
ing
agen
ts th
at a
ddre
ss
the
prev
entio
n of
the
cont
amin
atio
n of
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pr
oces
s mat
eria
ls, c
anna
bis,
cann
abis
-der
ived
pro
duct
s, or
con
tact
surfa
ces?
☐
☐
☐
D4.
2(h)
• Sa
nita
tion
requ
irem
ents
– D
oes t
he m
anuf
actu
ring,
pac
kagi
ng,
labe
ling,
or h
oldi
ng o
pera
tion(
s) h
ave
SOPs
, pro
cedu
res,
and
reco
rd k
eepi
ng in
pl
ace
for s
anita
tion
proc
edur
es p
erfo
rmed
by
all p
erso
nnel
dur
ing
the
ordi
nary
co
urse
of o
pera
tions
?
☐
☐
☐
D4.
2(i)(
1-2)
• Sa
nita
tion
requ
irem
ents
– D
oes t
he o
pera
tion
have
evi
denc
e th
at a
ll op
erat
ions
are
con
duct
ed in
acc
orda
nce
with
ade
quat
e sa
nita
tion
prin
cipl
es in
clud
ing
the
clea
ning
and
/or s
aniti
zing
of p
rodu
ctio
n eq
uipm
ent,
cont
aine
rs, a
nd o
ther
con
tact
surfa
ces,
cont
rolli
ng a
irbor
ne c
onta
min
atio
n as
ne
eded
whe
re c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, pr
oduc
t, or
con
tact
surfa
ces a
re e
xpos
ed?
☐
☐
☐
SAMPLE
D4.
2(i)(
3) •
Sani
tatio
n re
quir
emen
ts –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce fo
r pro
per s
anita
ry h
andl
ing
proc
edur
es?
☐
☐
☐
D4.
3(a)
(1-3
) • E
quip
men
t and
ute
nsils
– D
oes t
he p
rodu
ctio
n op
erat
ion
have
ev
iden
ce o
f the
requ
ired
use
of e
quip
men
t and
ute
nsils
that
are
of a
ppro
pria
te
desi
gn, c
onst
ruct
ion,
and
wor
kman
ship
suita
ble
for t
heir
inte
nded
use
, are
abl
e to
be
adeq
uate
ly c
lean
ed a
nd p
rope
rly m
aint
aine
d, a
nd w
ill n
ot re
sult
in th
e co
ntam
inat
ion
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, ca
nnab
is, c
anna
bis-
deriv
ed p
rodu
cts,
or c
onta
ct su
rface
s?
☐
☐
☐
D4.
3(b)
(1) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
pro
duct
ion
oper
atio
n ha
ve
evid
ence
that
all
equi
pmen
t and
ute
nsils
use
d in
the
prod
uctio
n op
erat
ion
are
inst
alle
d an
d m
aint
aine
d to
faci
litat
e cl
eani
ng o
f the
equ
ipm
ent,
uten
sils
, and
ad
jace
nt sp
aces
?
☐
☐
☐
D4.
3(b)
(2) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
pro
duct
ion
oper
atio
n ha
ve
evid
ence
that
all
equi
pmen
t and
ute
nsils
are
con
stru
cted
so th
at c
onta
ct
surfa
ces a
re n
onto
xic
and
corro
sion-
resi
stan
t, an
d ne
ither
reac
tive
nor
abso
rptiv
e?
☐
☐
☐
D4.
3(b)
(3) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
pro
duct
ion
oper
atio
n ha
ve
evid
ence
that
all
equi
pmen
t and
ute
nsils
are
des
igne
d an
d co
nstru
cted
to
with
stan
d th
e en
viro
nmen
t in
whi
ch th
ey a
re u
sed,
the
actio
n of
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s or c
anna
bis-
deriv
ed p
rodu
cts,
and,
if a
pplic
able
, cl
eani
ng c
ompo
unds
and
sani
tizin
g ag
ents
?
☐
☐
☐
D4.
3(b)
(4) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
pro
duct
ion
oper
atio
n ha
ve
evid
ence
that
all
equi
pmen
t and
ute
nsils
are
mai
ntai
ned
to p
rote
ct c
ompo
nent
s, in
-pro
cess
mat
eria
ls, c
anna
bis,
and
cann
abis
-der
ived
pro
duct
s fro
m b
eing
co
ntam
inat
ed b
y an
y so
urce
?
☐
☐
☐
D4.
3(c)
• E
quip
men
t and
ute
nsils
– D
oes t
he p
rodu
ctio
n op
erat
ion
have
ev
iden
ce th
at a
ll eq
uipm
ent a
nd u
tens
ils a
re d
esig
ned
and
mai
ntai
ned
to
min
imiz
e ac
cum
ulat
ion
of d
irt, f
ilth,
org
anic
mat
eria
l, pa
rticl
es o
f com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s and
can
nabi
s-de
rived
pro
duct
s, or
any
oth
er
extra
neou
s mat
eria
l or c
onta
min
ants
?
☐
☐
☐
SAMPLE
D4.
3(d)
• E
quip
men
t and
ute
nsils
– D
oes t
he p
rodu
ctio
n op
erat
ion
have
ev
iden
ce th
at c
ompr
esse
d ai
r or o
ther
gas
es in
trodu
ced
mec
hani
cally
into
or
onto
a c
ompo
nent
, pac
kagi
ng c
ompo
nent
, in-
proc
ess m
ater
ial,
cann
abis
or
cann
abis
-der
ived
pro
duct
, or c
onta
ct su
rface
, or u
sed
to c
lean
any
con
tact
su
rface
has
bee
n fil
tere
d or
oth
erw
ise
treat
ed su
ch th
at th
e co
mpo
nent
, pa
ckag
ing
com
pone
nt, i
n-pr
oces
s mat
eria
l, ca
nnab
is o
r can
nabi
s-de
rived
pr
oduc
t, or
con
tact
surfa
ce is
not
con
tam
inat
ed?
☐
☐
☐
D4.
3(e)
(1,2
) • E
quip
men
t and
ute
nsils
– D
oes t
he p
rodu
ctio
n op
erat
ion
have
ev
iden
ce th
at e
ach
freez
er, r
efrig
erat
or, a
nd o
ther
col
d-st
orag
e co
mpa
rtmen
t us
ed to
hol
d co
mpo
nent
s, in
-pro
cess
mat
eria
ls, o
r can
nabi
s or c
anna
bis-
deriv
ed
prod
ucts
is e
quip
ped
with
an
indi
catin
g th
erm
omet
er, t
empe
ratu
re-m
easu
ring
devi
ce, o
r tem
pera
ture
-rec
ordi
ng d
evic
e th
at in
dica
tes a
nd re
cord
s, or
allo
ws
for r
ecor
ding
by
hand
, the
tem
pera
ture
acc
urat
ely
with
in th
e co
mpa
rtmen
t; an
d is
equ
ippe
d w
ith a
n au
tom
ated
dev
ice
for r
egul
atin
g te
mpe
ratu
re a
nd/o
r an
auto
mat
ed a
larm
syst
em to
indi
cate
a si
gnifi
cant
tem
pera
ture
cha
nge?
☐
☐
☐
D4.
3(f)
• E
quip
men
t and
ute
nsils
– D
oes t
he p
rodu
ctio
n op
erat
ion
have
ev
iden
ce th
at a
ll in
stru
men
ts o
r con
trols
use
d in
the
man
ufac
turin
g, p
acka
ging
, la
belin
g, h
oldi
ng, o
r tes
ting;
or u
sed
to m
easu
re, r
egul
ate,
or r
ecor
d co
nditi
ons
that
con
trol o
r pre
vent
the
grow
th o
f mic
roor
gani
sms o
r oth
er c
onta
min
atio
n,
are
suita
bly
accu
rate
, pre
cise
, and
ade
quat
ely
mai
ntai
ned?
☐
☐
☐
D4.
3(g)
• E
quip
men
t and
ute
nsils
– D
oes t
he o
pera
tion
have
SO
Ps,
proc
edur
es, a
nd re
cord
kee
ping
in p
lace
that
, whe
re a
ppro
pria
te, e
nsur
e th
at
inst
rum
ents
and
con
trols
use
d in
man
ufac
turin
g, p
acka
ging
, hol
ding
, or t
estin
g co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s, an
d ca
nnab
is-d
eriv
ed p
rodu
cts a
re c
alib
rate
d, in
spec
ted,
or o
ther
wis
e ve
rifie
d be
fore
firs
t use
and
at r
outin
e in
terv
als o
r as o
ther
wis
e ne
cess
ary
to e
nsur
e th
e ac
cura
cy a
nd p
reci
sion
of t
he in
strum
ent o
r con
trol,
and
that
the
resu
lting
dat
a ar
e pe
riodi
cally
revi
ewed
by
qual
ity-c
ontro
l per
sonn
el?
Are
inst
rum
ents
or
cont
rols
that
are
pas
t the
ir ca
libra
tion,
insp
ectio
n, o
r ver
ifica
tion
due
date
, or
whi
ch c
anno
t be
adju
sted
to p
rovi
de su
itabl
e ac
cura
cy a
nd p
reci
sion
, rem
oved
fro
m u
se u
ntil
they
are
repa
ired
or re
plac
ed?
☐
☐
☐
SAMPLE
D4.
3(h)
(1,2
) • E
quip
men
t and
ute
nsils
– D
oes t
he o
pera
tion
have
SO
Ps,
proc
edur
es, a
nd re
cord
kee
ping
in p
lace
that
est
ablis
h an
d us
e ap
prop
riate
co
ntro
ls fo
r aut
omat
ed, m
echa
nica
l, an
d el
ectro
nic
equi
pmen
t (in
clud
ing
softw
are
for a
com
pute
r-co
ntro
lled
proc
ess)
to e
nsur
e th
at a
ny c
hang
es to
the
equi
pmen
t are
app
rove
d by
qua
lity-
cont
rol p
erso
nnel
and
inst
itute
d on
ly b
y au
thor
ize
pers
onne
l, as
wel
l as e
nsur
e th
at th
e eq
uipm
ent f
unct
ions
in
acco
rdan
ce w
ith it
s int
ende
d us
e?
☐
☐
☐
D4.
3(i)
(1) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce th
at e
nsur
e al
l equ
ipm
ent a
nd u
tens
ils,
and
any
othe
r con
tact
surfa
ces u
sed
are
prop
erly
mai
ntai
ned,
cle
aned
, and
sa
nitiz
ed, a
s nec
essa
ry, i
nclu
ding
the
taki
ng a
part,
as n
eces
sary
, for
thor
ough
m
aint
enan
ce, c
lean
ing,
and
sani
tizin
g?
☐
☐
☐
D4.
3(i)
(2) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce th
at e
nsur
es a
ll co
ntac
t sur
face
s use
d fo
r man
ufac
turin
g, p
acka
ging
, or h
oldi
ng lo
w- m
oist
ure
com
pone
nts,
in-
proc
ess m
ater
ials
, or c
anna
bis o
r can
nabi
s-de
rived
pro
duct
s are
in a
dry
and
sa
nita
ry c
ondi
tion
whe
n in
use
? W
hen
the
surfa
ces a
re w
et-c
lean
ed, a
re th
ey
sani
tized
, whe
n ne
cess
ary,
and
thor
ough
ly d
ried
befo
re su
bseq
uent
use
?
☐
☐
☐
D4.
3(i)
(3) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
, if w
et p
roce
ssin
g is
use
d du
ring
prod
uctio
n, a
ll co
ntac
t sur
face
s ar
e cl
eane
d an
d sa
nitiz
ed, a
s nec
essa
ry,
to p
rote
ct a
gain
st th
e in
trodu
ctio
n of
mic
roor
gani
sms i
nto
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
mat
eria
ls, o
r can
nabi
s or c
anna
bis-
deriv
ed
prod
ucts
?
☐
☐
☐
D4.
3(i)
(4) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
, whe
n cl
eani
ng a
nd
sani
tizin
g is
nec
essa
ry, a
ll co
ntac
t sur
face
s are
pro
perly
cle
aned
bef
ore
use
and
afte
r any
inte
rrup
tion
durin
g w
hich
the
cont
act s
urfa
ce m
ay h
ave
beco
me
cont
amin
ated
?
☐
☐
☐
D4.
3(i)
(5) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
, if c
onta
ct su
rface
s are
us
ed in
a c
ontin
uous
pro
duct
ion
oper
atio
n or
in c
onse
cutiv
e op
erat
ions
in
volv
ing
diffe
rent
bat
ches
of t
he sa
me
prod
uct,
the
cont
act s
urfa
ces a
re
adeq
uate
ly c
lean
ed a
nd sa
nitiz
ed, a
s nec
essa
ry?
☐
☐
☐
SAMPLE
D4.
3(i)
(6) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
all s
urfa
ces t
hat d
o no
t com
e in
to d
irect
con
tact
with
com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
m
ater
ials
, or c
anna
bis o
r can
nabi
s-de
rived
pro
duct
s are
cle
aned
as f
requ
ently
as
nec
essa
ry to
pro
tect
aga
inst
con
tam
inat
ing
com
pone
nts o
r pro
duct
s?
☐
☐
☐
D4.
3(i)
(7) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
sing
le-s
ervi
ce a
rticl
es
(suc
h as
ute
nsils
inte
nded
for o
ne-ti
me
use,
pap
er c
ups,
and
pape
r tow
els)
are
st
ored
in a
ppro
pria
te c
onta
iner
s and
han
dled
, dis
pens
ed, u
sed,
and
dis
pose
d of
in
a m
anne
r tha
t pro
tect
s aga
inst
con
tam
inat
ion
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, can
nabi
s or c
anna
bis-
deriv
ed p
rodu
cts,
or
any
cont
act s
urfa
ce?
☐
☐
☐
D4.
3(i)
(8) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
cle
anin
g co
mpo
unds
and
sa
nitiz
ing
agen
ts a
re a
dequ
ate
for t
heir
inte
nded
use
and
safe
und
er th
eir
cond
ition
s of u
se?
☐
☐
☐
D4.
3(i)
(9) •
Equ
ipm
ent a
nd u
tens
ils –
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
nece
ssar
y cl
eani
ng a
nd
sani
tizin
g of
por
tabl
e eq
uipm
ent a
nd u
tens
ils th
at h
ave
cont
act s
urfa
ces a
re
stor
ed in
a lo
catio
n an
d m
anne
r tha
t pro
tect
s the
m fr
om c
onta
min
atio
n?
☐
☐
☐
D4.
3(i)
(10)
• E
quip
men
t and
ute
nsils
– D
oes t
he o
pera
tion
have
SO
Ps,
proc
edur
es, a
nd re
cord
kee
ping
in p
lace
for t
he c
alib
ratio
n, m
aint
enan
ce,
clea
ning
, and
sani
tatio
n of
equ
ipm
ent,
inst
rum
ents
, and
ute
nsils
?
☐
☐
☐
D4.
4(a)
• Se
curi
ty r
equi
rem
ents
– D
oes t
he o
pera
tion
have
SO
Ps,
proc
edur
es, a
nd re
cord
-kee
ping
pro
toco
ls e
stab
lishe
d an
d im
plem
ente
d fo
r au
thor
ized
acc
ess t
o th
e ph
ysic
al p
lant
and
any
con
trolle
d ac
cess
are
as th
erei
n?
☐
☐
☐
D4.
4(b)
• Se
curi
ty r
equi
rem
ents
– D
oes t
he o
pera
tion
have
SO
Ps,
proc
edur
es, a
nd re
cord
kee
ping
pro
toco
ls in
pla
ce re
stric
ting
acce
ss to
the
phys
ical
pla
nt a
nd c
ontro
lling
acc
ess,
as n
eces
sary
, to
curr
ent p
erso
nnel
and
co
ntra
ctor
s as a
ppro
pria
te to
thei
r job
func
tion?
☐
☐
☐
SAMPLE
D4.
4(c)
(1-5
)(d)
• Se
curi
ty r
equi
rem
ents
– D
oes t
he o
pera
tion
have
SO
Ps,
proc
edur
es, a
nd re
cord
-kee
ping
pro
toco
ls in
pla
ce p
rovi
ding
one
or m
ore
cont
rolle
d ac
cess
are
as fo
r the
stor
age
of:
La
bels
and
oth
er p
acka
ging
com
pone
nts;
C
anna
bis a
nd c
anna
bis-
deriv
ed p
rodu
ctsp
;
C
anna
bis w
aste
;
Q
uara
ntin
ed c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss
mat
eria
ls, c
anna
bis,
or c
anna
bis-
deriv
ed p
rodu
cts.
☐
☐
☐
E5.
1(a)
(1) •
Man
ufac
turi
ng p
roto
col -
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd-k
eepi
ng p
roto
cols
in p
lace
for e
ach
uniq
ue fo
rmul
atio
n of
can
nabi
s-de
rived
pro
duct
pro
duce
d, in
clud
ing
the
iden
tity
of th
e pr
oduc
t?
☐
☐
☐
E5.
1(a)
(2)(
i-v) •
Man
ufac
turi
ng p
roto
col -
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
otoc
ols,
and
reco
rd-k
eepi
ng p
roto
cols
in p
lace
for e
ach
form
ulat
ion
of
prod
uct,
incl
udin
g no
min
al b
atch
size
; ide
ntity
of e
ach
com
pone
nt to
be
used
in
the
batc
h; w
eigh
t or m
easu
re o
f eac
h co
mpo
nent
to b
e us
ed in
the
batc
h,
incl
udin
g th
e un
it of
mea
sure
and
a st
atem
ent o
f any
rang
e or
var
iatio
n in
w
eigh
t or m
easu
re a
nd a
stat
emen
t of a
ny in
tent
iona
l ove
rage
am
ount
of a
co
mpo
nent
; and
the
nam
e an
d am
ount
of e
ach
ingr
edie
nt th
at w
ill b
e de
clar
ed
on th
e pr
oduc
t’s la
belin
g?
☐
☐
☐
E5.
1(a)
(3) •
Man
ufac
turi
ng p
roto
col -
Doe
s the
ope
ratio
n ha
ve S
OPs
, pr
oced
ures
, and
reco
rd k
eepi
ng p
roto
cols
in p
lace
for m
aint
aini
ng a
stat
emen
t of
theo
retic
al y
ield
for e
ach
sign
ifica
nt p
roce
ss st
ep a
nd a
t the
end
of
man
ufac
ture
, inc
ludi
ng th
e ac
cept
able
max
imum
and
min
imum
per
cent
ages
of
theo
retic
al y
ield
?
☐
☐
☐
SAMPLE
E5.
1(a)
(4)(
i-vii)
• M
anuf
actu
ring
pro
toco
l - D
oes t
he o
pera
tion
have
SO
Ps,
prot
ocol
s, an
d re
cord
kee
ping
in w
ritin
g or
ava
ilabl
e fo
r cro
ss re
fere
nce
for t
he
exec
utio
n of
eac
h pr
oces
s ste
p; p
rodu
ctio
n pr
oces
s spe
cific
atio
ns p
er s
ectio
n 5.
5; m
onito
ring
of p
rodu
ctio
n pr
oces
s spe
cific
atio
ns; i
n-pr
oces
s mat
eria
l sp
ecifi
catio
n pe
r sec
tion
5.8;
in-p
roce
ss m
ater
ial s
ampl
ing,
test
ing,
and
/or
exam
inat
ion;
can
nabi
s-de
rived
pro
duct
sam
plin
g, te
stin
g, a
nd/o
r exa
min
atio
n;
and
addi
tiona
l app
licab
le p
roce
dure
s to
be fo
llow
ed, i
f any
?
☐
☐
☐
E5.
1(a)
(4)(
i-vii)
• M
anuf
actu
ring
pro
toco
l - D
oes t
he o
pera
tion
have
SO
Ps,
prot
ocol
s, an
d re
cord
kee
ping
des
crib
ing
the
prod
uctio
n pr
oces
s tha
t ens
ures
al
l can
nabi
s-de
rived
pro
duct
spec
ifica
tions
are
con
sist
ently
met
?
☐
☐
☐
E5.
2(a)
• M
anuf
actu
ring
com
pone
nt c
ontr
ol r
equi
rem
ents
- D
oes t
he
oper
atio
n ha
ve th
e re
quire
d w
ritte
n SO
Ps, p
roto
cols,
and
reco
rd k
eepi
ng in
pl
ace
desc
ribin
g, in
suffi
cien
t det
ail,
the
rece
ipt,
iden
tific
atio
n, st
orag
e,
hand
ling,
sam
plin
g, re
view
, and
app
rova
l or r
ejec
tion
of c
ompo
nent
s?
☐
☐
☐
E5.
2(b)
• M
anuf
actu
ring
com
pone
nt c
ontr
ol r
equi
rem
ents
- D
oes t
he
oper
atio
n ha
ve th
e re
quire
d w
ritte
n SO
Ps, p
roto
cols,
and
reco
rd k
eepi
ng in
pl
ace
to p
rope
rly id
entif
y ea
ch c
onta
iner
or g
roup
of c
onta
iner
s for
co
mpo
nent
s with
a d
istin
ctiv
e co
de (e
.g. l
ot o
r con
trol n
umbe
r) fo
r eac
h lo
t in
each
ship
men
t rec
eive
d th
at a
llow
s the
lot t
o be
trac
ed b
ackw
ard
to th
e su
pplie
r, th
e da
te re
ceiv
ed, a
nd th
e na
me
of th
e co
mpo
nent
; and
forw
ard
to th
e ca
nnab
is-d
eriv
ed p
rodu
ct b
atch
es m
anuf
actu
red
or d
istri
bute
d us
ing
the
lot?
Is
the
code
use
d in
reco
rdin
g th
e di
spos
ition
of e
ach
lot,
as re
quire
d?
☐
☐
☐
E5.
2(c)
(1,2
) • M
anuf
actu
ring
com
pone
nt c
ontr
ol r
equi
rem
ents
- D
oes t
he
oper
atio
n ha
ve th
e re
quire
d w
ritte
n SO
Ps, p
roto
cols,
and
reco
rd k
eepi
ng in
pl
ace
prop
erly
des
crib
ing
the
spec
ifica
tions
for e
ach
com
pone
nt, t
o th
e ex
tent
th
ey a
re n
eces
sary
to e
nsur
e th
at m
anuf
actu
red
batc
hes o
f can
nabi
s-de
rived
pr
oduc
t mee
t spe
cific
atio
ns a
s fol
low
s: re
quire
d es
tabl
ishm
ent o
f ide
ntity
sp
ecifi
catio
n fo
r the
com
pone
nt; a
nd re
quire
d sp
ecifi
catio
ns fo
r the
stre
ngth
an
d co
mpo
sitio
n of
the
com
pone
nt a
s nec
essa
ry to
ens
ure
the
stre
ngth
and
co
mpo
sitio
n of
can
nabi
s-de
rived
pro
duct
s man
ufac
ture
d w
ith th
e co
mpo
nent
?
☐
☐
☐
SAMPLE
E5.
2(c)
(3) •
Man
ufac
turi
ng c
ompo
nent
con
trol
req
uire
men
ts -
Doe
s the
op
erat
ion
have
the
requ
ired
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
plac
e pr
oper
ly d
escr
ibin
g th
e re
quire
d sp
ecifi
catio
ns fo
r the
pur
ity o
f the
co
mpo
nent
as n
eces
sary
to e
nsur
e th
e pu
rity
of c
anna
bis-
deriv
ed p
rodu
cts
man
ufac
ture
d w
ith th
e co
mpo
nent
, inc
ludi
ng li
mits
on
thos
e ty
pes o
f co
ntam
inat
ion
that
may
adu
ltera
te o
r lea
d to
adu
ltera
tion
of c
anna
bis-
deriv
ed
prod
ucts
man
ufac
ture
d w
ith th
e co
mpo
nent
, suc
h as
filth
, ins
ect i
nfes
tatio
n,
mic
robi
olog
ical
con
tam
inat
ion,
or o
ther
con
tam
inan
ts?
☐
☐
☐
E5.
2(d)
(1) •
Man
ufac
turi
ng c
ompo
nent
con
trol
req
uire
men
ts -
Doe
s the
op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at a
ll co
mpo
nent
s rec
eive
d an
d st
ored
pen
ding
app
rova
l are
han
dled
as
follo
ws:
upo
n re
ceip
t and
bef
ore
acce
ptan
ce, e
ach
cont
aine
r or g
roup
ing
of
cont
aine
rs is
requ
ired
to b
e ex
amin
ed v
isua
lly fo
r app
ropr
iate
labe
ling
as to
co
nten
ts, c
onta
iner
dam
age
or b
roke
n se
als,
and
cont
amin
atio
n, d
eter
min
ing
whe
ther
the
cont
aine
r con
ditio
n m
ay h
ave
resu
lted
in c
onta
min
atio
n or
de
terio
ratio
n of
the
com
pone
nts?
☐
☐
☐
E5.
2(d)
(2,3
) • M
anuf
actu
ring
com
pone
nt c
ontr
ol r
equi
rem
ents
- D
oes t
he
oper
atio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
all
com
pone
nts r
ecei
ved
and
stor
ed p
endi
ng a
ppro
val a
re h
andl
ed a
s fo
llow
s: th
e su
pplie
rs d
ocum
enta
tion
for e
ach
ship
men
t is t
horo
ughl
y ex
amin
ed to
ens
ure
the
com
pone
nts a
re c
onsi
sten
t with
wha
t was
ord
ered
; and
th
at th
e co
mpo
nent
s are
stor
ed u
nder
qua
rant
ine
until
they
hav
e be
en sa
mpl
ed,
revi
ewed
, and
app
rove
d or
reje
cted
by
qual
ity-c
ontro
l per
sonn
el?
☐
☐
☐
E5.
2(e)
(1) •
Man
ufac
turi
ng c
ompo
nent
con
trol
req
uire
men
ts -
Doe
s the
op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at a
ll co
mpo
nent
s are
app
rove
d or
reje
cted
as f
ollo
ws:
eac
h lo
t of
com
pone
nts m
ust b
e w
ithhe
ld fr
om u
se u
ntil
the
lot h
as b
een
sam
pled
, re
view
ed, a
nd re
leas
ed fo
r use
by
qual
ity- c
ontro
l per
sonn
el?
☐
☐
☐
E5.
2(e)
(2) •
Man
ufac
turi
ng c
ompo
nent
con
trol
req
uire
men
ts -
Doe
s the
op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at a
ll co
mpo
nent
s are
det
erm
ined
to b
e in
com
plia
nce
with
est
ablis
hed
spec
ifica
tion
eith
er th
roug
h re
view
of t
he su
pplie
r’s c
ertif
icat
e of
ana
lysi
s or
othe
r doc
umen
tatio
n, o
r thr
ough
app
ropr
iate
test
and
/or e
xam
inat
ions
? A
re
any
test
s and
exa
min
atio
ns c
ondu
cted
usi
ng a
ppro
pria
te sc
ient
ifica
lly v
alid
m
etho
ds, a
s req
uire
d?
☐
☐
☐
SAMPLE
E5.
2(e)
(3) •
Man
ufac
turi
ng c
ompo
nent
con
trol
req
uire
men
ts -
Doe
s the
op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at a
ny lo
t of a
com
pone
nt th
at m
eets
its s
peci
ficat
ions
is a
ppro
ved
and
rele
ased
for u
se b
y qu
ality
-con
trol p
erso
nnel
?
☐
☐
☐
E5.
2(e)
(4) •
Man
ufac
turi
ng c
ompo
nent
con
trol
req
uire
men
ts -
Doe
s the
op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at a
ny lo
t of a
com
pone
nt th
at d
oes n
ot m
eet i
ts sp
ecifi
catio
ns is
reje
cted
by
qual
ity-c
ontro
l per
sonn
el, u
nles
s qua
lity-
cont
rol p
erso
nnel
just
ify a
nd a
ppro
ve
a tre
atm
ent,
proc
ess a
djus
tmen
t, re
proc
essi
ng, o
r oth
er d
evia
tion
that
will
re
nder
the
com
pone
nt o
r pac
kagi
ng c
ompo
nent
suita
ble
for u
se a
nd w
ill e
nsur
e th
e fin
ishe
d ca
nnab
is p
rodu
ct b
atch
es m
anuf
actu
red
with
the
affe
cted
lot w
ill
mee
t all
spec
ifica
tions
for i
dent
ity, p
urity
, stre
ngth
, and
com
posi
tion
and
will
no
t be
othe
rwis
e co
ntam
inat
ed o
r adu
ltera
ted.
☐
☐
☐
E5.
3(a)
• M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
doc
umen
ting
a m
anuf
actu
ring
batc
h re
cord
of e
ach
batc
h of
can
nabi
s-de
rived
pro
duct
man
ufac
ture
d?
☐
☐
☐
E5.
3(b)
(1-2
) • M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
the
man
ufac
turin
g ba
tch
num
ber i
s abl
e to
be
cros
s-re
fere
nced
or r
epro
duce
the
appr
opria
te m
anuf
actu
ring
prot
ocol
as w
ell a
s for
m a
com
plet
e re
cord
of t
he
man
ufac
turin
g an
d co
ntro
l of t
he b
atch
?
☐
☐
☐
E5.
3(c)
• M
anuf
actu
ring
bat
ch r
ecor
d- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at e
ach
batc
h is
as
sign
ed a
bat
ch, l
ot, o
r con
trol n
umbe
r allo
win
g th
e co
mpl
ete
hist
ory
of th
e pr
oduc
tion
and
dist
ribut
ion
of th
e ba
tch
to b
e de
term
ined
? Is
the
code
use
d in
re
cord
ing
the
disp
ositi
on o
f eac
h ba
tch,
as r
equi
red?
☐
☐
☐
E5.
3(d)
(1-3
) • M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce re
quiri
ng th
e ba
tch
reco
rd
to in
clud
e, a
s app
licab
le to
the
proc
ess,
the
iden
tity
of th
e ca
nnab
is-d
eriv
ed
prod
uct;
the
batc
h, lo
t or c
ontro
l num
ber o
f the
can
nabi
s-de
rived
pro
duct
; and
th
e ba
tch
size
?
☐
☐
☐
SAMPLE
E5.
3(d)
(4)(
i-iii)
• M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce fo
r eac
h co
mpo
nent
use
d in
pro
duct
ion
of a
bat
ch th
at in
clud
es th
e id
entit
y of
eac
h co
mpo
nent
use
d in
th
e ba
tch;
the
batc
h, lo
t, or
con
trol n
umbe
r of e
ach
com
pone
nt u
sed
in th
e ba
tch;
and
the
actu
al w
eigh
t or m
easu
re o
f eac
h ba
tch
or lo
t of c
ompo
nent
use
d in
the
batc
h, in
clud
ing
the
unit
of m
easu
re?
☐
☐
☐
E5.
3(d)
(5) •
Man
ufac
turi
ng b
atch
rec
ord
- Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce n
otin
g th
e da
te(s
) on
whi
ch a
nd,
whe
re a
pplic
able
, the
tim
e(s)
at w
hich
eac
h st
ep o
f the
man
ufac
turin
g pr
oces
s w
as p
erfo
rmed
?
☐
☐
☐
E5.
3(d)
(6) •
Man
ufac
turi
ng b
atch
rec
ord
- Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce n
otin
g th
e ac
tual
resu
lts o
btai
ned
durin
g m
onito
ring
of p
rodu
ctio
n pr
oces
s par
amet
ers?
☐
☐
☐
E5.
3(d)
(7) •
Man
ufac
turi
ng b
atch
rec
ord
- Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce n
otin
g th
e id
entit
y of
pro
cess
ing
lines
and
maj
or e
quip
men
t use
d in
pro
duci
ng th
e ba
tch?
☐
☐
☐
E5.
3(d)
(8) •
Man
ufac
turi
ng b
atch
rec
ord
- Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce n
otin
g th
e da
te a
nd, w
here
ap
plic
able
, the
tim
e of
the
mai
nten
ance
, cle
anin
g, a
nd/o
r san
itizi
ng o
f the
m
ajor
equ
ipm
ent u
sed
in p
rodu
cing
the
batc
h, o
r a c
ross
- ref
eren
ce to
reco
rds
such
as i
ndiv
idua
l equ
ipm
ent l
ogs w
here
this
info
rmat
ion
is re
cord
ed.
☐
☐
☐
E5.
3(d)
(9) •
Man
ufac
turi
ng b
atch
rec
ord
- Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce n
otin
g, if
man
ufac
ture
of t
he
batc
h us
es e
quip
men
t or i
nstru
men
ts re
quiri
ng p
erio
dic
calib
ratio
n, in
spec
tion,
or
ver
ifica
tion,
the
date
and
, whe
re a
pplic
able
, the
tim
e of
the
last
cal
ibra
tion,
in
spec
tion,
or v
erifi
catio
n, o
r the
dat
e on
whi
ch su
ch is
nex
t due
; or a
cro
ss-
refe
renc
e to
reco
rds,
such
as i
ndiv
idua
l equ
ipm
ent l
ogs,
whe
re th
is in
form
atio
n is
reco
rded
?
☐
☐
☐
SAMPLE
E5.
3(d)
(10)
• M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
incl
udin
g a
stat
emen
t of t
he
actu
al y
ield
and
a st
atem
ent r
egar
ding
whe
ther
the
actu
al y
ield
is w
ithin
the
acce
ptab
le ra
nge
of th
e th
eore
tical
yie
ld a
s per
sect
ion
5.1(
a)(3
) afte
r eac
h si
gnifi
cant
pro
cess
step
and
at t
he e
nd o
f man
ufac
turin
g?
☐
☐
☐
E5.
3(d)
(11)
• M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
rega
rdin
g an
y ca
nnab
is w
aste
gen
erat
ed
durin
g th
e pr
oduc
tion
of a
bat
ch?
☐
☐
☐
E5.
3(d)
(12)
• M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
doc
umen
ting
any
treat
men
t, pr
oces
s ad
just
men
t, re
proc
essi
ng, o
r oth
er d
evia
tion
that
occ
urre
d du
ring
prod
uctio
n of
th
e ba
tch
?
☐
☐
☐
E5.
3(d)
(13)
• M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
incl
udin
g re
cord
s of t
he d
ate,
tim
e w
here
ap
plic
able
, qua
ntity
, and
per
son
resp
onsi
ble
for a
ny sa
mpl
e re
mov
ed d
urin
g or
af
ter p
rodu
ctio
n?
☐
☐
☐
E5.
3(d)
(14)
• M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
of t
he a
ctua
l res
ults
of a
ny te
stin
g or
ex
amin
atio
n of
in-p
roce
ss m
ater
ial o
r can
nabi
s-de
rived
pro
duct
, or a
cro
ss-
refe
renc
e to
such
resu
lts?
☐
☐
☐
E5.
3(d)
(15)
• M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
incl
udin
g do
cum
enta
tion
that
the
cann
abis
-der
ived
pro
duct
mee
ts it
s spe
cific
atio
ns fo
r ide
ntity
, pur
ity, s
treng
th,
and
com
posi
tion,
in a
ccor
danc
e w
ith th
e re
quire
men
ts o
f the
man
ufac
turin
g pr
otoc
ol?
☐
☐
☐
SAMPLE
E5.
3(d)
(15)
(i-vi
i) • M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng a
dequ
ate
to re
cord
the
iden
tity
of
each
per
son
perfo
rmin
g ea
ch p
roce
ss st
ep in
pro
duct
ion
of th
e ba
tch,
incl
udin
g bu
t not
lim
ited
to:
W
eigh
ing
or m
easu
ring
each
com
pone
nt a
nd v
erify
ing
the
wei
ght o
r m
easu
re o
f eac
h co
mpo
nent
use
d in
the
batc
h pe
r sec
tion
5.4;
Add
ing
each
com
pone
nt to
the
batc
h an
d ve
rifyi
ng th
e ad
ditio
n of
ea
ch c
ompo
nent
to th
e ba
tch
per s
ectio
n 5.
4;
(ii
i) M
onito
ring
prod
uctio
n pr
oces
s par
amet
ers;
(iv) P
erfo
rmin
g an
d ve
rifyi
ng c
alcu
latio
ns o
f the
act
ual y
ield
and
any
ot
her m
athe
mat
ical
cal
cula
tions
;
Dire
ctly
ove
rsee
ing
each
stag
e of
pro
duct
ion
of th
e ba
tch;
Perfo
rmin
g an
y ot
her c
heck
s or v
erifi
catio
ns in
pro
duct
ion
of th
e ba
tch,
as n
eede
d; a
nd
R
elea
sing
the
batc
h fro
m o
ne st
age
of p
rodu
ctio
n to
the
next
.
☐
☐
☐
E5.
3(e)
• M
anuf
actu
ring
bat
ch r
ecor
d - D
oes t
he o
pera
tion
have
evi
denc
e th
at a
ll da
ta in
the
man
ufac
turin
g ba
tch
reco
rd is
reco
rded
at t
he ti
me
at w
hich
ea
ch a
ctio
n is
per
form
ed?
☐
☐
☐
E5.
3(f)
• Man
ufac
turi
ng b
atch
rec
ord
- Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
the
com
plet
ed m
anuf
actu
ring
batc
h re
cord
for e
ach
batc
h ha
s bee
n re
view
ed a
nd si
gned
by
qual
ity-c
ontro
l per
sonn
el to
det
erm
ine
com
plia
nce
with
all
appl
icab
le sp
ecifi
catio
ns a
nd o
ther
requ
irem
ents
of t
he m
anuf
actu
ring
prot
ocol
bef
ore
a ba
tch
is a
ppro
ved?
☐
☐
☐
E5.
4(a)
• A
lloca
tion
and
char
ge-in
of c
ompo
nent
s - D
oes t
he o
pera
tion
have
w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng fo
r the
wei
ghin
g, m
easu
ring,
and
su
bdiv
idin
g of
com
pone
nts t
o be
use
d in
a c
anna
bis-
deriv
ed p
rodu
ct b
atch
as
appr
opria
te fo
r the
bat
ch?
☐
☐
☐
E5.
4(b)
(1-4
) • A
lloca
tion
and
char
ge-in
of c
ompo
nent
s - D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
if a
com
pone
nt is
rem
oved
fro
m th
e or
igin
al c
onta
iner
to a
noth
er id
entif
ying
the
new
con
tain
er w
ith th
e fo
llow
ing
info
rmat
ion:
Com
pone
nt id
entit
y;
B
atch
, lot
, or c
ontro
l num
ber;
W
eigh
t or m
easu
re in
the
new
con
tain
er; a
nd
B
atch
for w
hich
com
pone
nt w
as d
ispe
nsed
, inc
ludi
ng it
s ide
ntity
and
ba
tch,
lot,
or c
ontro
l num
ber.
☐
☐
☐
SAMPLE
E5.
4(c)
(1-3
) • A
lloca
tion
and
char
ge-in
of c
ompo
nent
s - D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
ver
ifyin
g th
at e
ach
cont
aine
r of
com
pone
nt d
ispen
sed
to m
anuf
actu
ring
has b
een
exam
ined
by
a se
cond
pe
rson
or v
erifi
ed b
y au
tom
ated
equ
ipm
ent t
o as
sure
that
the
com
pone
nt w
as
rele
ased
by
qual
ity-c
ontro
l per
sonn
el; t
he w
eigh
t or m
easu
re is
cor
rect
as
stat
ed in
the
man
ufac
turin
g pr
otoc
ol; a
nd th
e co
ntai
ner(
s) a
re p
rope
rly
iden
tifie
d?
☐
☐
☐
E5.
4(d)
• A
lloca
tion
and
char
ge-in
of c
ompo
nent
s - D
oes t
he o
pera
tion
have
w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng v
erify
ing
that
eac
h co
mpo
nent
has
be
en a
dded
to th
e ba
tch
by o
ne p
erso
n an
d ve
rifie
d by
a se
cond
per
son
or, i
f th
e co
mpo
nent
s are
add
ed b
y au
tom
ated
equ
ipm
ent,
verif
ied
by o
ne p
erso
n?
☐
☐
☐
E5.
5(a)
(1-4
) • P
roce
ss m
onito
ring
and
con
trol
s dur
ing
man
ufac
turi
ng –
D
oes t
he o
pera
tion
have
evi
denc
e th
at re
quire
d pr
oces
s spe
cific
atio
ns h
ave
been
est
ablis
hed
for p
rodu
ctio
n pr
oces
s par
amet
ers a
t or d
urin
g an
y po
int,
step
, or
stag
e w
here
con
trol i
s nec
essa
ry to
ens
ure
the
qual
ity o
f the
bat
ch o
f ca
nnab
is-d
eriv
ed p
rodu
ct, a
nd to
det
ect a
ny u
nant
icip
ated
occ
urre
nce
that
may
re
sult
in c
onta
min
atio
n, a
dulte
ratio
n, o
r a fa
ilure
to m
eet s
peci
ficat
ions
. Do
the
proc
ess p
aram
eter
s mon
itore
d in
clud
e th
e fo
llow
ing
as a
ppro
pria
te: t
ime;
te
mpe
ratu
re, p
ress
ure;
and
spee
d?
☐
☐
☐
E5.
5(b)
• Pr
oces
s mon
itori
ng a
nd c
ontr
ols d
urin
g m
anuf
actu
ring
– D
oes
the
oper
atio
n ha
ve e
vide
nce
that
the
prod
uctio
n pr
oces
s par
amet
ers a
re
mon
itore
d at
or d
urin
g an
y po
int,
step
, or s
tage
whe
n pr
oces
s spe
cific
atio
ns
have
bee
n es
tabl
ishe
d?
☐
☐
☐
E5.
5(c)
• Pr
oces
s m
onito
ring
and
con
trol
s dur
ing
man
ufac
turi
ng -
Doe
s th
e op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
do
cum
entin
g an
d ju
stify
ing
any
devi
atio
n fro
m th
e sp
ecifi
ed p
roce
ss
para
met
ers a
nd q
uara
ntin
e an
y as
soci
ated
in-p
roce
ss m
ater
ial o
r pro
duct
? A
re
any
devi
atio
ns re
view
ed a
nd a
ppro
ved
or re
ject
ed b
y qu
ality
-con
trol
pers
onne
l? D
o qu
ality
-con
trol p
erso
nnel
app
rove
such
dev
iatio
ns o
nly
afte
r de
term
inin
g th
at th
e re
sulti
ng c
anna
bis-
deriv
ed p
rodu
ct w
ill m
eet a
ll sp
ecifi
catio
ns fo
r ide
ntity
, pur
ity, s
treng
th, a
nd c
ompo
sitio
n an
d is
not
ot
herw
ise
cont
amin
ated
or a
dulte
rate
d?
☐
☐
☐
SAMPLE
E5.
5(d)
• Pr
oces
s mon
itori
ng a
nd c
ontr
ols d
urin
g m
anuf
actu
ring
- D
oes
the
oper
atio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce
show
ing
that
if a
dev
iatio
n is
reje
cted
, the
resu
lting
in-p
roce
ss o
r fin
ishe
d ca
nnab
is-d
eriv
ed p
rodu
ct sh
all b
e re
ject
ed, u
nles
s qua
lity-
cont
rol p
erso
nnel
ap
prov
e a
treat
men
t, pr
oces
s adj
ustm
ent,
repr
oces
sing
, or o
ther
dev
iatio
n th
at
ensu
res t
he c
anna
bis-
der
ived
pro
duct
bat
ches
man
ufac
ture
d w
ith th
e af
fect
ed
mat
eria
l will
mee
t all
spec
ifica
tions
for i
dent
ity, p
urity
, stre
ngth
, and
co
mpo
sitio
n an
d w
ill n
ot b
e ot
herw
ise
cont
amin
ated
or a
dulte
rate
d? I
s any
su
ch tr
eatm
ent,
proc
ess a
djus
tmen
t, re
proc
essi
ng, o
r oth
er d
evia
tion
docu
men
ted,
just
ified
, and
app
rove
d by
qua
lity-
cont
rol p
erso
nnel
, as
requ
ired?
.
☐
☐
☐
E5.
5(e)
• Pr
oces
s m
onito
ring
and
con
trol
s dur
ing
man
ufac
turi
ng -
Doe
s th
e op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
en
surin
g th
e pr
oper
iden
tific
atio
n of
all
com
poun
ding
and
stor
age
cont
aine
rs,
proc
essi
ng li
nes,
and
maj
or e
quip
men
t use
d du
ring
the
prod
uctio
n of
a b
atch
of
cann
abis
-der
ived
pro
duct
at a
ll tim
es to
indi
cate
thei
r con
tent
s and
, whe
n ne
cess
ary,
the
phas
e of
pro
cess
ing
of th
e ba
tch?
☐
☐
☐
E5.
5(f)
• Pro
cess
mon
itori
ng a
nd c
ontr
ols d
urin
g m
anuf
actu
ring
– D
oes
the
oper
atio
n ha
ve e
vide
nce
that
ope
ratio
ns o
n on
e co
mpo
nent
, pro
duct
, or
batc
h is
, as r
equi
red,
phy
sica
lly, s
patia
lly, o
r tem
pora
lly se
para
ted
from
op
erat
ions
on
othe
r com
pone
nts,
prod
ucts
, or b
atch
es?
☐
☐
☐
SAMPLE
E5.
5(g)
(1-4
) • P
roce
ss m
onito
ring
and
con
trol
s dur
ing
man
ufac
turi
ng -
Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols,
and
reco
rd k
eepi
ng in
pla
ce
ensu
ring
that
all
nece
ssar
y pr
ecau
tions
hav
e be
en ta
ken
durin
g th
e m
anuf
actu
re
of a
can
nabi
s-de
rived
pro
duct
s to
prev
ent c
onta
min
atio
n of
com
pone
nts a
nd
prod
ucts
? Th
ese
prec
autio
ns in
clud
e, b
ut a
re n
ot li
mite
d to
:
Was
hing
or c
lean
ing
com
pone
nts t
hat c
onta
in so
il or
oth
er
cont
amin
ants
;
Hol
ding
com
pone
nts,
in-p
roce
ss m
ater
ials
, and
can
nabi
s or c
anna
bis-
deriv
ed p
rodu
cts a
ppro
pria
tely
;
Prev
entin
g cr
oss-
cont
amin
atio
n an
d m
ix-u
ps b
etw
een
cont
amin
ated
co
mpo
nent
s, in
-pro
cess
mat
eria
ls, a
nd c
anna
bis o
r can
nabi
s-de
rived
pr
oduc
ts a
nd u
ncon
tam
inat
ed it
ems
U
sing
effe
ctiv
e m
easu
res t
o pr
otec
t aga
inst
the
incl
usio
n of
met
al o
r ot
her f
orei
gn m
ater
ial i
n co
mpo
nent
s or c
anna
bis p
rodu
cts,
by, f
or
exam
ple:
◦
Filte
rs, s
train
ers,
or si
eves
; ◦
Trap
s;
◦ M
agne
ts;
◦ El
ectro
nic
met
al d
etec
tors
.
☐
☐
☐
E5.
6(a)
• M
anuf
actu
ring
sam
plin
g re
quir
emen
ts -
Doe
s the
ope
ratio
n ha
ve
evid
ence
that
a re
pres
enta
tive
sam
ple
of e
ach
batc
h or
lot o
f com
pone
nt,
cann
abis
, or c
anna
bis-
deriv
ed p
rodu
ct h
as b
een
colle
cted
by
rem
ovin
g an
d co
mpo
sitin
g po
rtion
s of m
ater
ial o
r uni
ts fr
om th
roug
hout
the
cont
aine
rs in
the
batc
h or
lot?
☐
☐
☐
E5.
6(b)
• M
anuf
actu
ring
sam
plin
g re
quir
emen
ts –
Doe
s the
ope
ratio
n ha
ve
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at, i
f add
ition
al
repr
esen
tativ
e sa
mpl
es o
r oth
er sa
mpl
es a
re ta
ken
as a
ppro
pria
te, t
he fo
llow
ing
take
s pla
ce?
M
onito
ring
of th
e qu
ality
of i
n-pr
oces
s mat
eria
ls d
urin
g pr
oduc
tion;
Exam
inat
ion
of th
e de
gree
of v
aria
bilit
y of
mat
eria
ls o
r pro
duct
s; an
d
Inve
stig
atio
n of
kno
wn
or su
spec
ted
non-
conf
orm
ance
s.
☐
☐
☐
SAMPLE
E5.
6(c)
(1-4
) • M
anuf
actu
ring
sam
plin
g re
quir
emen
ts -
Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
doc
umen
ting
the
num
ber o
f co
ntai
ners
and
the
amou
nt o
f mat
eria
l or u
nits
to b
e re
mov
ed fr
om e
ach
cont
aine
r bas
ed o
n ap
prop
riate
crit
eria
, suc
h as
:
Qua
ntity
nee
ded
for t
estin
g, e
xam
inat
ion,
and
rese
rve;
Past
qua
lity
hist
ory
of th
e ite
m;
Ex
pect
ed v
aria
bilit
y of
the
mat
eria
l or u
nits
bei
ng sa
mpl
ed; a
nd
D
egre
e of
con
fiden
ce a
nd p
reci
sion
requ
ired?
☐
☐
☐
E5.
6(d)
• M
anuf
actu
ring
sam
plin
g re
quir
emen
ts -
Doe
s the
ope
ratio
n ha
ve
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at th
e co
ntai
ners
se
lect
ed fo
r sam
plin
g ha
ve b
een
base
d on
ratio
nal c
riter
ia su
ch a
s ran
dom
sa
mpl
ing
or d
irect
ed sa
mpl
ing,
as a
ppro
pria
te?
E5.
6(e)
• M
anuf
actu
ring
sam
plin
g re
quir
emen
ts -
Doe
s the
ope
ratio
n ha
ve
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at sa
mpl
es a
re
colle
cted
in a
ccor
danc
e w
ith th
e fo
llow
ing
proc
edur
es?
Th
e co
ntai
ners
sele
cted
for s
ampl
ing
have
bee
n cl
eane
d w
hen
nece
ssar
y in
a m
anne
r to
prev
ent i
ntro
duct
ion
of c
onta
min
ants
into
th
e co
mpo
nent
, in-
pro
cess
mat
eria
l, ca
nnab
is o
r can
nabi
s-de
rived
pr
oduc
t.
Th
e co
ntai
ners
hav
e be
en o
pene
d, sa
mpl
ed, a
nd re
seal
ed in
a m
anne
r de
sign
ed to
pre
vent
con
tam
inat
ion
of th
eir c
onte
nts a
nd
cont
amin
atio
n of
oth
er c
ompo
nent
s, in
-pro
cess
mat
eria
ls, c
anna
bis,
or c
anna
bis-
deriv
ed p
rodu
ct.
St
erile
equ
ipm
ent a
nd a
sept
ic sa
mpl
ing
tech
niqu
es h
ave
been
use
d w
hen
nece
ssar
y.
W
here
app
ropr
iate
for t
he p
urpo
se o
f the
sam
ple
and
the
natu
re o
f th
e m
ater
ial b
eing
sam
pled
, sam
ple
porti
ons a
re re
mov
ed fr
om th
e to
p, m
iddl
e, a
nd b
otto
m o
f con
tain
ers.
Such
sam
ple
porti
ons m
ay b
e co
mpo
site
d in
form
ing
the
repr
esen
tativ
e sa
mpl
e or
may
be
test
ed
sepa
rate
ly, a
s app
ropr
iate
to th
e pu
rpos
e.
C
onta
iner
s fro
m w
hich
sam
ples
hav
e be
en ta
ken
mus
t be
mar
ked
to
indi
cate
that
sam
ples
hav
e be
en re
mov
ed fr
om th
em.
SAMPLE
E5.
6(f)
• Man
ufac
turi
ng sa
mpl
ing
requ
irem
ents
– D
oes t
he o
pera
tion
have
ev
iden
ce th
at a
ll sa
mpl
e co
ntai
ners
are
iden
tifie
d w
ith th
e fo
llow
ing
info
rmat
ion?
Nam
e of
the
item
sam
pled
;
Bat
ch, l
ot, o
r con
trol n
umbe
r of t
he it
em sa
mpl
ed;
C
onta
iner
from
whi
ch th
e sa
mpl
e w
as ta
ken,
or f
or sa
mpl
es
take
n di
rect
ly fo
r the
pro
duct
ion
line,
the
equi
pmen
t lin
e an
d tim
e at
whi
ch th
e sa
mpl
e w
as ta
ken,
unl
ess s
uch
info
rmat
ion
is
docu
men
ted
sepa
rate
ly;
D
ate
on w
hich
the
sam
ple
was
take
n;
N
ame
of th
e pe
rson
who
col
lect
ed th
e sa
mpl
e; a
nd
Q
uant
ity a
nd u
nit o
f mea
sure
of t
he sa
mpl
e.
E5.
6(g)
• M
anuf
actu
ring
sam
plin
g re
quir
emen
ts –
Doe
s the
ope
ratio
n ha
ve
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at e
ach
sam
ple
rem
oved
from
a b
atch
or l
ot is
reco
rded
in th
e in
vent
ory
or m
anuf
actu
ring
batc
h re
cord
for t
he b
atch
or l
ot?
☐
☐
☐
E5.
6(h)
• M
anuf
actu
ring
sam
plin
g re
quir
emen
ts -
Doe
s the
ope
ratio
n ha
ve
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at th
e qu
antit
y of
sa
mpl
e us
ed fo
r eac
h te
st o
r exa
min
atio
n is
of s
uffic
ient
size
or n
umbe
r to
ensu
re th
e re
sults
are
repr
esen
tativ
e of
the
batc
h or
lot?
☐
☐
☐
E5.
6(i)
• Man
ufac
turi
ng sa
mpl
ing
requ
irem
ents
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
a re
serv
e sa
mpl
e ha
s bee
n pr
epar
ed fr
om th
e re
pres
enta
tive
sam
ple
of e
ach
batc
h or
lot o
f she
lf-st
able
com
pone
nt, c
anna
bis,
or c
anna
bis-
deriv
ed p
rodu
ct?
☐
☐
☐
E5.
6(j)
• Man
ufac
turi
ng sa
mpl
ing
requ
irem
ents
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng to
ens
ure
that
all
rese
rve
sam
ples
con
sist
of
at l
east
twic
e th
e qu
antit
y ne
cess
ary
for t
ests
and
exa
min
atio
ns to
det
erm
ine
whe
ther
the
shel
f-st
able
com
pone
nt, c
anna
bis,
or c
anna
bis-
deriv
ed p
rodu
ct
mee
ts e
stab
lishe
d cr
itica
l qua
lity
spec
ifica
tions
? W
here
stat
e la
w li
mits
the
amou
nt o
f can
nabi
s and
can
nabi
s-de
rived
pro
duct
per
mitt
ed to
be
kept
on
hand
, ope
ratio
ns m
ay k
eep
smal
ler a
mou
nts i
n re
serv
e, a
s nec
essa
ry.
☐
☐
☐
E5.
6(k)
(1) •
Man
ufac
turi
ng sa
mpl
ing
requ
irem
ents
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng to
ens
ure
that
rese
rve
sam
ples
of
shel
f-sta
ble
com
pone
nts a
re st
ored
usin
g an
app
ropr
iate
con
tain
er-c
losu
re to
pr
otec
t aga
inst
con
tam
inat
ion
or d
eter
iora
tion
durin
g st
orag
e?
☐
☐
☐
SAMPLE
E5.
6(k)
(2) •
Man
ufac
turi
ng sa
mpl
ing
requ
irem
ents
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng to
ens
ure
that
rese
rve
sam
ples
of
shel
f-sta
ble
com
pone
nts a
re st
ored
und
er c
ondi
tions
con
sist
ent w
ith th
e co
nditi
ons u
nder
whi
ch th
e co
mpo
nent
is st
ored
at t
he m
anuf
actu
ring
oper
atio
n?
☐
☐
☐
E5.
6(k)
(3) •
Man
ufac
turi
ng sa
mpl
ing
requ
irem
ents
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng to
ens
ure
that
rese
rve
sam
ples
of
shel
f-sta
ble
com
pone
nts a
re re
tain
ed fo
r one
yea
r pas
t the
exp
iratio
n da
te o
f th
e la
st b
atch
of c
anna
bis-
der
ived
pro
duct
man
ufac
ture
d fro
m th
e lo
t? W
here
st
ate
law
lim
its th
e am
ount
of c
anna
bis a
nd c
anna
bis-
deriv
ed p
rodu
ct
perm
itted
are
kep
t on
hand
, ope
ratio
ns m
ay k
eep
rese
rve
sam
ples
for s
horte
r pe
riods
of t
ime,
as n
eces
sary
.
☐
☐
☐
E5.
6(l)(
1) •
Man
ufac
turi
ng sa
mpl
ing
requ
irem
ents
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce to
ens
ure
that
the
rese
rve
sam
ples
of c
anna
bis-
deriv
ed p
rodu
ct is
pro
perly
stor
ed u
sing
the
sam
e co
ntai
ner-
clos
ure
syst
em in
whi
ch th
e pa
ckag
ed a
nd la
bele
d ca
nnab
is-d
eriv
ed
prod
uct i
s dis
tribu
ted
or, f
or b
ulk
prod
ucts
, usi
ng a
con
tain
er-c
losu
re sy
stem
th
at p
rovi
des e
ssen
tially
the
sam
e ch
arac
teris
tics t
o pr
otec
t aga
inst
co
ntam
inat
ion
or d
eter
iora
tion
as th
e on
e in
whi
ch th
e bu
lk p
rodu
ct is
di
strib
uted
?
☐
☐
☐
E5.
6(l)(
2) •
Man
ufac
turi
ng sa
mpl
ing
requ
irem
ents
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce to
ens
ure
that
rese
rve
sam
ples
of c
anna
bis-
deriv
ed p
rodu
ct(s
) are
stor
ed u
nder
con
ditio
ns c
onsi
sten
t w
ith th
e st
orag
e co
nditi
ons r
ecom
men
ded
on th
e pr
oduc
t lab
el o
r, if
no st
orag
e co
nditi
ons a
re re
com
men
ded
on th
e la
bel,
unde
r ord
inar
y st
orag
e co
nditi
ons?
☐
☐
☐
E5.
6(l)(
3) •
Man
ufac
turi
ng sa
mpl
ing
requ
irem
ents
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce to
ens
ure
that
rese
rve
sam
ples
of c
anna
bis-
deriv
ed p
rodu
ct a
re re
tain
ed fo
r one
yea
r pas
t the
ex
pira
tion
date
of t
he b
atch
or l
ot?
Whe
re st
ate
law
lim
its th
e am
ount
of
cann
abis
and
can
nabi
s-de
rived
pro
duct
s per
mitt
ed to
be
kept
on
hand
, op
erat
ions
may
kee
p re
serv
e sa
mpl
es fo
r sho
rter p
erio
ds o
f tim
e, a
s nec
essa
ry.
☐
☐
☐
SAMPLE
E5.
7(a)
(1-2
) • C
anna
bis-
deri
ved
prod
uct s
peci
ficat
ions
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce e
stab
lishi
ng sp
ecifi
catio
ns
for e
ach
cann
abis
-der
ived
pro
duct
? In
clud
ing;
The
esta
blis
hing
spec
ifica
tion
for t
he id
entit
y, p
urity
, stre
ngth
, and
co
mpo
sitio
n of
eac
h ca
nnab
is-d
eriv
ed p
rodu
ct m
anuf
actu
red
by th
e op
erat
ion;
and
If re
ceiv
ing
cann
abis
-der
ived
pro
duct
s for
furth
er p
roce
ssin
g,
spec
ifica
tions
to p
rovi
de su
ffici
ent a
ssur
ance
that
the
prod
uct
rece
ived
is a
dequ
atel
y id
entif
ied
and
is c
onsi
sten
t with
the
purc
hase
or
der.
☐
☐
☐
E5.
7(b)
(1) •
Can
nabi
s-de
rive
d pr
oduc
t spe
cific
atio
ns -
Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
con
firm
ing
that
eac
h ba
tch
or lo
t of c
anna
bis-
deriv
ed p
rodu
ct o
r sub
set o
f can
nabi
s-de
rived
pro
duct
m
anuf
actu
red
by th
e op
erat
ion
has b
een
iden
tifie
d th
roug
h so
und
stat
istic
al
sam
plin
g pl
an?
Doe
s the
ope
ratio
n ve
rify
that
the
batc
h or
lot m
eets
pro
duct
sp
ecifi
catio
ns fo
r ide
ntity
, pur
ity, s
treng
th, a
nd c
ompo
sitio
n, to
the
exte
nt th
at
scie
ntifi
cally
val
id te
st m
etho
ds e
xist
for t
hese
spec
ifica
tions
?
☐
☐
☐
E5.
7(b)
(2) •
Can
nabi
s-de
rive
d pr
oduc
t spe
cific
atio
ns -
Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
con
firm
ing
that
for e
ach
batc
h or
lot o
f can
nabi
s-de
rived
pro
duct
, in
lieu
of te
stin
g ev
ery
esta
blis
hed
stre
ngth
and
com
posi
tion
spec
ifica
tion
for w
hich
scie
ntifi
cally
val
id te
st
met
hods
exi
st, o
ne o
r mor
e st
reng
th a
nd/o
r com
posi
tion
spec
ifica
tions
has
be
en se
lect
ed fo
r tes
ting,
whe
re it
can
be
esta
blis
hed
that
test
ing
for t
his
redu
ced
pane
l of s
peci
ficat
ions
is su
ffici
ent t
o en
sure
that
the
prod
uctio
n an
d pr
oces
s con
trol s
yste
m is
pro
duci
ng p
rodu
ct th
at m
eets
all
spec
ifica
tions
?
☐
☐
☐
E5.
7(b)
(3) •
Can
nabi
s-de
rive
d pr
oduc
t spe
cific
atio
ns -
Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
con
firm
ing
that
for e
ach
batc
h or
lot o
f can
nabi
s-de
rived
pro
duct
, whe
re n
o sc
ient
ifica
lly v
alid
test
m
etho
d ex
ists
for a
pro
duct
spec
ifica
tion,
com
plia
nce
with
the
spec
ifica
tion
has b
een
esta
blis
hed
thro
ugh
com
pone
nt a
nd/o
r in-
proc
ess t
estin
g,
exam
inat
ions
, or m
onito
ring
and/
or re
view
of m
anuf
actu
ring
batc
h re
cord
s?
☐
☐
☐
E5.
7(b)
(4) •
Can
nabi
s-de
rive
d pr
oduc
t spe
cific
atio
ns -
Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
con
firm
ing
that
eac
h ba
tch
or lo
t of c
anna
bis-
deriv
ed p
rodu
ct h
as b
een
appr
oved
by
qual
ity-c
ontro
l pe
rson
nel a
nd ju
stifi
ed fo
r red
uced
pro
duct
test
ing
unde
r sec
tion
5.7(
b)(2
) or
sect
ion
5.7(
b)(3
) of t
his p
art?
☐
☐
☐
SAMPLE
E5.
7(c)
• C
anna
bis-
deri
ved
prod
uct s
peci
ficat
ions
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce c
onfir
min
g th
at e
ach
batc
h or
lot
of c
anna
bis-
deriv
ed p
rodu
ct th
at fa
ils to
mee
t its
spec
ifica
tions
is re
ject
ed,
unle
ss q
ualit
y-co
ntro
l per
sonn
el a
ppro
ve a
trea
tmen
t, pr
oces
s adj
ustm
ent,
repr
oces
sing
, or o
ther
dev
iatio
n th
at e
nsur
es th
e ca
nnab
is-d
eriv
ed p
rodu
ct
batc
hes m
anuf
actu
red
with
the
affe
cted
mat
eria
l will
mee
t all
spec
ifica
tions
for
iden
tity,
pur
ity, s
treng
th, a
nd c
ompo
sitio
n, a
nd w
ill n
ot b
e ot
herw
ise
cont
amin
ated
or a
dulte
rate
d? I
s any
such
trea
tmen
t, pr
oces
s adj
ustm
ent,
repr
oces
sing
, or o
ther
dev
iatio
n do
cum
ente
d in
the
man
ufac
turin
g ba
tch
reco
rd, j
ustif
ied,
and
app
rove
d by
qua
lity-
cont
rol p
erso
nnel
, as r
equi
red?
☐
☐
☐
E5.
7(d)
• C
anna
bis-
deri
ved
prod
uct s
peci
ficat
ions
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce c
onfir
min
g th
at e
ach
batc
h or
lot
of c
anna
bis-
deriv
ed p
rodu
ct e
xper
ienc
ing
any
unex
plai
ned
occu
rren
ce o
r di
scre
panc
y, a
nd a
ny fa
ilure
of t
he c
anna
bis-
deriv
ed p
rodu
ct to
mee
t its
sp
ecifi
catio
ns o
r req
uire
men
ts, h
as b
een
docu
men
ted
and
inve
stig
ated
? Th
e in
vest
igat
ion
mus
t ext
end
to a
ny re
late
d ba
tche
s tha
t may
hav
e be
en a
ssoc
iate
d w
ith th
e sa
me
spec
ific
failu
re, d
iscre
panc
y, o
r pro
blem
; thi
s may
incl
ude,
but
is
not
lim
ited
to, b
atch
es o
f the
sam
e ca
nnab
is-d
eriv
ed p
rodu
ct, o
ther
bat
ches
pr
oces
sed
on th
e sa
me
equi
pmen
t or d
urin
g th
e sa
me
time
perio
d, a
nd
othe
r bat
ches
pro
duce
d us
ing
the
sam
e lo
ts o
f com
pone
nts.
☐
☐
☐
E5.
7(e)
• C
anna
bis-
deri
ved
prod
uct s
peci
ficat
ions
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce d
escr
ibin
g, in
suffi
cien
t det
ail,
the
stor
age,
han
dlin
g, sa
mpl
ing,
test
ing,
and
app
rova
l or r
ejec
tion
of a
ll ca
nnab
is a
nd c
anna
bis-
deriv
ed p
rodu
cts?
☐
☐
☐
SAMPLE
E5.
8(a)
(1-8
) • In
-pro
cess
mat
eria
l spe
cific
atio
ns, s
ampl
ing,
and
test
ing
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce
esta
blis
hing
in-p
roce
ss sp
ecifi
catio
n fo
r any
poi
nt, s
tep,
or s
tage
in th
e m
anuf
actu
ring
prot
ocol
whe
re c
ontro
l is n
eces
sary
to h
elp
ensu
re th
at
spec
ifica
tions
are
met
for t
he id
entit
y, p
urity
, stre
ngth
, and
com
posi
tion
of th
e ca
nnab
is-d
eriv
ed p
rodu
ct?
Such
spec
ifica
tions
may
incl
ude,
but
are
not
lim
ited
to, t
he fo
llow
ing,
as a
ppro
pria
te:
W
eigh
t or f
ill o
f tab
lets
, cap
sule
s, or
oth
er u
nits
;
Wei
ght o
r fill
var
iatio
n of
tabl
ets,
caps
ules
, or o
ther
uni
ts;
H
ardn
ess o
r fria
bilit
y of
tabl
ets;
Dis
inte
grat
ion
time
of u
nit d
osag
es;
C
larit
y, v
isco
sity
, spe
cific
gra
vity
, tot
al d
isso
lved
solid
s, or
pH
of
solu
tions
;
Loss
of d
ryin
g, m
oist
ure
cont
ent,
or s
olve
nt re
sidue
;
Mic
robi
olog
ical
cha
ract
eris
tics;
and
Org
anol
eptic
cha
ract
eris
tics.
☐
☐
☐
E5.
8(b)
• In
-pro
cess
mat
eria
l spe
cific
atio
ns, s
ampl
ing,
and
test
ing
- Doe
s th
e op
erat
ion
have
evi
denc
e th
at th
e in
-pro
cess
spec
ifica
tions
for s
uch
char
acte
ristic
s mee
t the
requ
ired
cons
iste
ncy
with
the
cann
abis
-der
ived
pr
oduc
t spe
cific
atio
ns?
☐
☐
☐
E5.
8(c)
• In
-pro
cess
mat
eria
l spe
cific
atio
ns, s
ampl
ing,
and
test
ing
- Doe
s th
e op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
al
l in-
proc
ess m
ater
ials
hav
e be
en sa
mpl
ed a
nd te
sted
or e
xam
ined
for
conf
orm
ance
with
in-p
roce
ss sp
ecifi
catio
ns a
s app
ropr
iate
dur
ing
the
prod
uctio
n pr
oces
s (e.
g., a
t com
men
cem
ent o
r com
plet
ion
of si
gnifi
cant
pr
oces
s sta
ges o
r afte
r sto
rage
for l
ong
perio
ds),
and
whe
re a
ppro
pria
te h
ave
been
app
rove
d or
reje
cted
by
qual
ity-c
ontro
l per
sonn
el?
☐
☐
☐
E5.
8(d)
• In
-pro
cess
mat
eria
l spe
cific
atio
ns, s
ampl
ing,
and
test
ing
- Doe
s th
e op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
al
l in-
proc
ess m
ater
ial t
hat f
ails
to m
eet i
ts sp
ecifi
catio
ns a
re re
ject
ed, u
nles
s qu
ality
-con
trol p
erso
nnel
app
rove
a tr
eatm
ent,
proc
ess a
djus
tmen
t, re
proc
essi
ng, o
r oth
er d
evia
tion
that
will
ens
ure
the
cann
abis
-der
ived
pro
duct
ba
tche
s man
ufac
ture
d w
ith th
e af
fect
ed m
ater
ial w
ill m
eet a
ll sp
ecifi
catio
ns fo
r id
entit
y, p
urity
, stre
ngth
, and
com
posi
tion
and
will
not
be
othe
rwis
e co
ntam
inat
ed o
r adu
ltera
ted?
Is a
ny su
ch tr
eatm
ent,
proc
ess a
djus
tmen
t, re
proc
essi
ng, o
r oth
er d
evia
tion
docu
men
ted
in th
e m
anuf
actu
ring
batc
h re
cord
, jus
tifie
d, a
nd a
ppro
ved
by q
ualit
y-co
ntro
l per
sonn
el, a
s req
uire
d?
☐
☐
☐
SAMPLE
E5.
9(a)
• C
alcu
latio
n of
yie
ld -
Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
all
actu
al y
ield
s are
det
erm
ined
at t
he
conc
lusio
n of
eac
h ap
prop
riate
pha
se o
f man
ufac
turin
g of
the
cann
abis
-der
ived
pr
oduc
t? A
re su
ch c
alcu
latio
ns e
ither
per
form
ed b
y on
e pe
rson
and
in
depe
nden
tly v
erifi
ed b
y a
seco
nd p
erso
n, o
r, if
the
yiel
d is
cal
cula
ted
by
auto
mat
ed e
quip
men
t, in
depe
nden
tly v
erifi
ed b
y on
e pe
rson
, as r
equi
red?
☐
☐
☐
E5.
9(b)
• C
alcu
latio
n of
yie
ld -
Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
if th
e pe
rcen
tage
of t
heor
etic
al y
ield
, at
any
proc
ess s
tep
or a
t the
end
of p
rodu
ctio
n, fa
lls o
utsid
e th
e m
axim
um o
r m
inim
um p
erce
ntag
e of
theo
retic
al y
ield
allo
wed
in th
e m
anuf
actu
ring
prot
ocol
, tha
t qua
lity-
cont
rol p
erso
nnel
are
requ
ired
to c
ondu
ct a
n in
vest
igat
ion
of th
e ba
tch
and
dete
rmin
e, to
the
exte
nt p
ossi
ble,
the
sour
ce o
f th
e di
scre
panc
y? A
re d
evia
tions
doc
umen
ted,
exp
lain
ed, a
nd a
ppro
ved
by
qual
ity-c
ontro
l per
sonn
el, a
s req
uire
d?.
☐
☐
☐
F6.1
(a) •
Gen
eral
con
side
ratio
n fo
r pa
ckag
ing
com
pone
nts,
incl
udin
g la
bels
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce
for c
anna
bis t
o be
pac
kage
d w
ithou
t und
ergo
ing
man
ufac
turin
g to
a c
anna
bis-
deriv
ed p
rodu
ct, d
ocum
entin
g it
as re
ceiv
ed, i
dent
ified
, sto
red,
han
dled
, sa
mpl
ed, r
evie
wed
, and
app
rove
d or
reje
cted
as p
er se
ctio
ns 5
.2 a
nd 5
.6
abov
e?
☐
☐
☐
F6.1
(b) •
Gen
eral
con
side
ratio
n fo
r pa
ckag
ing
com
pone
nts,
incl
udin
g la
bels
- D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce
esta
blis
hing
spec
ifica
tions
for p
acka
ging
com
pone
nts a
s nec
essa
ry to
ens
ure
the
iden
tity,
pur
ity, s
treng
th, a
nd c
ompo
sitio
n of
the
pack
aged
pro
duct
s?
Pack
agin
g co
mpo
nent
s tha
t may
com
e in
to c
onta
ct w
ith p
rodu
cts m
ust b
e sa
fe
and
suita
ble
for t
heir
inte
nded
use
and
mus
t not
be
reac
tive
or a
bsor
ptiv
e or
ot
herw
ise
affe
ct th
e sa
fety
, pur
ity, o
r qua
lity
of th
e pr
oduc
t.
☐
☐
☐
F6.1
(c) •
Gen
eral
con
side
ratio
n fo
r pa
ckag
ing
com
pone
nts,
incl
udin
g la
bels
- D
oes t
he p
acka
ging
and
labe
ling
oper
atio
n ha
ve w
ritte
n SO
Ps,
prot
ocol
s, an
d re
cord
kee
ping
in p
lace
est
ablis
hing
pro
cedu
res d
escr
ibin
g, in
su
ffici
ent d
etai
l, th
e re
ceip
t, id
entif
icat
ion,
stor
age,
han
dlin
g, a
nd a
ppro
val o
r re
ject
ion
of p
acka
ging
and
labe
ling
com
pone
nts?
☐
☐
☐
SAMPLE
F6.1
(d)(
1) •
Gen
eral
con
side
ratio
n fo
r pa
ckag
ing
com
pone
nts,
incl
udin
g la
bels
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
pla
ce fo
r the
rece
ivin
g an
d st
orag
e of
labe
ls a
nd o
ther
pac
kagi
ng
com
pone
nts t
o en
sure
that
, upo
n re
ceip
t and
bef
ore
acce
ptan
ce, e
ach
cont
aine
r or
gro
upin
g of
con
tain
ers o
f pac
kagi
ng c
ompo
nent
s is v
isua
lly e
xam
ined
for
appr
opria
te la
belin
g as
to c
onte
nts,
cont
aine
r dam
age
or b
roke
n se
als,
and
cont
amin
atio
n, to
det
erm
ine
whe
ther
the
cont
aine
r con
ditio
n m
ay h
ave
resu
lted
in c
onta
min
atio
n or
det
erio
ratio
n of
the
pack
agin
g co
mpo
nent
s?
☐
☐
☐
F6.1
(d)(
2) •
Gen
eral
con
side
ratio
n fo
r pa
ckag
ing
com
pone
nts,
incl
udin
g la
bels
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
pla
ce v
erify
ing
that
the
supp
lier’
s doc
umen
tatio
n fo
r eac
h sh
ipm
ent h
as
been
exa
min
ed to
ens
ure
the
pack
agin
g co
mpo
nent
s are
con
sist
ent w
ith w
hat
was
ord
ered
?
☐
☐
☐
F6.1
(d)(
3) •
Gen
eral
con
side
ratio
n fo
r pa
ckag
ing
com
pone
nts,
incl
udin
g la
bels
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
pla
ce e
nsur
ing
that
eac
h co
ntai
ner o
r gro
upin
g of
con
tain
ers f
or p
acka
ging
co
mpo
nent
s has
bee
n id
entif
ied
with
a d
istin
ctiv
e co
de (i
.e. l
ot o
r con
trol
num
ber)
for e
ach
lot i
n ea
ch sh
ipm
ent r
ecei
ved,
whi
ch a
llow
s the
lot t
o be
tra
ced
back
war
d to
the
supp
lier,
incl
udin
g th
e da
te re
ceiv
ed, a
nd th
e na
me
of
the
com
pone
nt, a
nd fo
rwar
ded
to th
e pr
oduc
t bat
ches
pac
kage
d or
labe
led
usin
g th
e lo
t? T
his c
ode
mus
t be
used
in re
cord
ing
the
disp
ositi
on o
f eac
h lo
t.
☐
☐
☐
F6.1
(d)(
4) •
Gen
eral
con
side
ratio
n fo
r pa
ckag
ing
com
pone
nts,
incl
udin
g la
bels
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
pla
ce e
nsur
ing
that
labe
ls a
nd o
ther
pac
kagi
ng c
ompo
nent
s are
stor
ed u
nder
qu
aran
tine
until
they
hav
e be
en e
xam
ined
and
app
rove
d or
reje
cted
by
qual
ity-
cont
rol p
erso
nnel
?
☐
☐
☐
F6.1
(e)(1
) • G
ener
al c
onsi
dera
tion
for
pack
agin
g co
mpo
nent
s, in
clud
ing
labe
ls -
Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng
in p
lace
ens
urin
g th
at p
acka
ging
com
pone
nts a
re w
ithhe
ld fr
om u
se u
ntil
the
lot h
as b
een
revi
ewed
and
rele
ased
for u
se b
y th
e qu
ality
-con
trol p
erso
nnel
?
☐
☐
☐
F6.1
(e)(2
) • G
ener
al c
onsi
dera
tion
for
pack
agin
g co
mpo
nent
s, in
clud
ing
labe
ls -
Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng
in p
lace
ens
urin
g th
at p
acka
ging
com
pone
nts a
re in
com
plia
nce
with
es
tabl
ishe
d sp
ecifi
catio
ns a
nd h
ave
been
thor
ough
ly e
xam
ined
upo
n re
ceip
t, an
d/or
has
und
ergo
ne a
revi
ew o
f the
supp
lier’
s doc
umen
tatio
n?
☐
☐
☐
SAMPLE
F6.1
(e)(3
) • G
ener
al c
onsi
dera
tion
for
pack
agin
g co
mpo
nent
s, in
clud
ing
labe
ls -
Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng
in p
lace
ens
urin
g th
at a
ll sh
ipm
ents
of a
pac
kagi
ng c
ompo
nent
hav
e be
en
dete
rmin
ed to
mee
t its
spec
ifica
tion
and
rele
ased
for u
se b
y qu
ality
-con
trol
pers
onne
l?
☐
☐
☐
F6.1
(e)(4
) • G
ener
al c
onsi
dera
tion
for
pack
agin
g co
mpo
nent
s, in
clud
ing
labe
ls -
Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng
in p
lace
ens
urin
g th
at a
ll pa
ckag
ing
com
pone
nt th
at d
oes n
ot m
eet i
ts
spec
ifica
tions
, inc
ludi
ng a
ny in
corr
ect l
abel
s, ar
e re
ject
ed b
y qu
ality
-con
trol
pers
onne
l, un
less
qua
lity-
cont
rol p
erso
nnel
app
rove
a tr
eatm
ent o
r oth
er
devi
atio
n th
at w
ill re
nder
the
pack
agin
g co
mpo
nent
suita
ble
for u
se, a
nd w
ill
ensu
re th
e pr
oduc
t bat
ches
pac
kage
d an
d la
bele
d w
ith th
e af
fect
ed c
ompo
nent
w
ill m
eet a
ll sp
ecifi
catio
ns fo
r ide
ntity
, pur
ity, s
treng
th, c
ompo
sitio
n,
pack
agin
g, a
nd la
belin
g an
d w
ill n
ot b
e ot
herw
ise
cont
amin
ated
or a
dulte
rate
d?
Is a
ny su
ch tr
eatm
ent o
r oth
er d
evia
tion
docu
men
ted,
just
ified
, and
app
rove
d by
qua
lity-
cont
rol p
erso
nnel
, as r
equi
red?
☐
☐
☐
F6.1
(f) •
Gen
eral
con
side
ratio
n fo
r pa
ckag
ing
com
pone
nts,
incl
udin
g la
bels
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
pla
ce p
rohi
bitin
g th
e us
e of
gan
g-pr
inte
d la
belin
g fo
r diff
eren
t pro
duct
s, or
di
ffere
nt st
reng
ths o
r net
con
tent
s of t
he sa
me
prod
uct,
unle
ss th
e la
belin
g fro
m
gang
-prin
ted
shee
ts is
ade
quat
ely
diffe
rent
iate
d by
size
, sha
pe, o
r col
or?
☐
☐
☐
F6.2
(a)(
1) •
Pack
agin
g an
d/or
labe
ling
prot
ocol
- D
oes t
he p
acka
ging
and
la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
fo
r eac
h un
ique
pro
duct
to b
e pa
ckag
ed a
nd/o
r lab
eled
that
ass
ures
the
corr
ect
pack
agin
g an
d la
belin
g co
mpo
nent
s are
use
d fo
r eac
h pr
oduc
t pac
kage
d or
la
bele
d by
the
oper
atio
n in
clud
ing
the
iden
tity
of th
e pr
oduc
t to
be p
acka
ged
and/
or la
bele
d? W
here
app
ropr
iate
, the
pac
kagi
ng a
nd/o
r lab
elin
g pr
otoc
ol
may
be
com
bine
d w
ith th
e m
anuf
actu
ring
prot
ocol
for t
he p
rodu
ct.
☐
☐
☐
F6.2
(a)(
2) •
Pack
agin
g an
d/or
labe
ling
prot
ocol
- D
oes t
he p
acka
ging
and
la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
fo
r eac
h un
ique
pro
duct
to b
e pa
ckag
ed a
nd/o
r lab
eled
that
ass
ures
the
corr
ect
pack
agin
g an
d la
belin
g co
mpo
nent
s are
use
d fo
r eac
h pr
oduc
t pac
kage
d or
la
bele
d by
the
oper
atio
n, in
clud
ing
the
iden
tity
of e
ach
pack
agin
g co
mpo
nent
to
be
used
? W
here
app
ropr
iate
, the
pac
kagi
ng a
nd/o
r lab
elin
g pr
otoc
ol m
ay b
e co
mbi
ned
with
the
man
ufac
turin
g pr
otoc
ol fo
r the
pro
duct
.
☐
☐
☐
SAMPLE
F6.2
(a)(
3) •
Pack
agin
g an
d/or
labe
ling
prot
ocol
- D
oes t
he p
acka
ging
and
la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
fo
r eac
h un
ique
pro
duct
to b
e pa
ckag
ed a
nd/o
r lab
eled
that
ass
ures
the
corr
ect
pack
agin
g an
d la
belin
g co
mpo
nent
s are
use
d fo
r eac
h pr
oduc
t pac
kage
d or
la
bele
d by
the
oper
atio
n in
clud
ing
prov
idin
g a
spec
imen
of t
he la
bel a
nd o
ther
la
belin
g to
be
used
, or a
cro
ss-r
efer
ence
to th
e la
belin
g (s
uch
as b
y la
bel
num
ber a
nd v
ersi
on n
umbe
r)?
Whe
re a
ppro
pria
te, t
he p
acka
ging
and
/or
labe
ling
prot
ocol
may
be
com
bine
d w
ith th
e m
anuf
actu
ring
prot
ocol
for t
he
prod
uct.
☐
☐
☐
F6.2
(a)(
4) •
Pack
agin
g an
d/or
labe
ling
prot
ocol
- D
oes t
he p
acka
ging
and
la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
fo
r eac
h un
ique
pro
duct
to b
e pa
ckag
ed a
nd/o
r lab
eled
that
ass
ures
the
corr
ect
pack
agin
g an
d la
belin
g co
mpo
nent
s are
use
d fo
r eac
h pr
oduc
t pac
kage
d or
la
bele
d by
the
oper
atio
n pr
ovid
ing
a st
atem
ent o
f the
acc
epta
ble
max
imum
and
m
inim
um p
erce
ntag
es o
f the
oret
ical
yie
ld?
☐
☐
☐
F6.2
(a)(
5)(i-
vi) •
Pac
kagi
ng a
nd/o
r la
belin
g pr
otoc
ol -
Doe
s the
pac
kagi
ng
and
labe
ling
oper
atio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pl
ace
for e
ach
uniq
ue p
rodu
ct to
be
pack
aged
and
/or l
abel
ed th
at a
ssur
es th
e co
rrec
t pac
kagi
ng a
nd la
belin
g co
mpo
nent
s are
use
d fo
r eac
h pr
oduc
t pa
ckag
ed o
r lab
eled
by
the
oper
atio
n, to
incl
ude
writ
ten
inst
ruct
ions
or c
ross
re
fere
nces
to st
anda
rd p
roce
dure
s for
the
follo
win
g?
In
spec
tion
of p
acka
ging
and
labe
ling
equi
pmen
t bef
ore
and
afte
r use
to
ass
ure
that
all
prod
ucts
and
pac
kagi
ng a
nd la
belin
g m
ater
ials
from
pr
evio
us o
pera
tions
hav
e be
en re
mov
ed;
Is
suan
ce o
f lab
els a
nd la
belin
g an
d la
belin
g sp
ecifi
ed in
the
pack
agin
g an
d/or
labe
ling
prot
ocol
;
Car
eful
exa
min
atio
n of
labe
ls a
nd la
belin
g is
sued
to e
ach
batc
h pr
ior
to u
se, t
o en
sure
con
form
ity to
the
labe
ling
spec
ified
in th
e pa
ckag
ing
and/
or la
belin
g pr
otoc
ol;
Ea
ch p
acka
ging
and
/or l
abel
ing
proc
ess s
tep;
Mon
itorin
g of
pac
kagi
ng a
nd/o
r lab
elin
g pr
oces
s ste
ps; a
nd
A
dditi
onal
app
licab
le p
roce
dure
s to
be fo
llow
ed, i
f any
.
☐
☐
☐
F6.2
(b) •
Pac
kagi
ng a
nd/o
r la
belin
g pr
otoc
ol -
Doe
s the
ope
ratio
n ha
ve
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at th
e pa
ckag
ing
and/
or la
belin
g pr
oces
s mee
ts a
ll pr
oduc
t spe
cific
atio
ns?
☐
☐
☐
SAMPLE
F6.2
(c) •
Pac
kagi
ng a
nd/o
r la
belin
g pr
otoc
ol -
Doe
s the
ope
ratio
n ha
ve
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for t
he p
acka
ging
and
/or
labe
ling
proc
ess d
escr
ibed
in th
e pr
otoc
ols t
hat e
nsur
e th
e pr
oduc
t sp
ecifi
catio
ns a
re c
onsi
sten
tly m
et?
☐
☐
☐
F6.3
(a) •
Pac
kagi
ng a
nd/o
r la
belin
g ba
tch
reco
rd -
Doe
s the
ope
ratio
n ha
ve
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for t
he p
repa
ratio
n of
a
pack
agin
g an
d/or
labe
ling
batc
h re
cord
for e
ach
batc
h or
lot o
f pro
duct
pa
ckag
ed a
nd/o
r lab
eled
by
the
oper
atio
n? W
here
app
ropr
iate
, the
pac
kagi
ng
and
labe
ling
batc
h re
cord
may
be
com
bine
d w
ith th
e m
anuf
actu
ring
batc
h re
cord
for t
he b
atch
or l
ot.
☐
☐
☐
F6.3
(b)(
1-2)
• Pa
ckag
ing
and/
or la
belin
g ba
tch
reco
rd -
Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce fo
r the
pac
kagi
ng
and/
or la
belin
g of
bat
ch re
cord
s, in
clud
ing
cros
s-re
fere
nce
or re
prod
uctio
n of
ap
prop
riate
pac
kagi
ng a
nd/o
r lab
elin
g pr
otoc
ol, a
nd a
com
plet
e re
cord
of t
he
pack
agin
g an
d/or
labe
ling
and
sam
plin
g of
the
batc
h?
☐
☐
☐
F6.3
(c)(1
-3) •
Pac
kagi
ng a
nd/o
r la
belin
g ba
tch
reco
rd -
Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce fo
r the
pac
kagi
ng
and/
or la
belin
g w
ith b
atch
reco
rds i
nclu
ding
, as a
pplic
able
to th
e pr
oces
s, th
e id
entit
y of
the
prod
uct;
batc
h, lo
t, or
con
trol n
umbe
r of t
he p
rodu
ct; p
acka
ging
an
d/or
labe
ling
batc
h si
ze?
☐
☐
☐
F6.3
(c)(4
)(i-i
ii) •
Pack
agin
g an
d/or
labe
ling
batc
h re
cord
- D
oes t
he
oper
atio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce fo
r pa
ckag
ing
and/
or la
belin
g of
bat
ch re
cord
s tha
t inc
lude
, as a
pplic
able
to th
e pr
oces
s, fo
r eac
h pa
ckag
ing
com
pone
nt u
sed
in th
e pr
oduc
tion
of th
e ba
tch,
the
follo
win
g in
form
atio
n:
Id
entit
y of
eac
h pa
ckag
ing
com
pone
nt;
B
atch
, lot
, or c
ontro
l num
ber o
f eac
h pa
ckag
ing
com
pone
nt u
sed
in
the
batc
h;
Q
uant
ity o
f eac
h lo
t of p
acka
ging
com
pone
nts u
sed,
incl
udin
g th
e un
it of
mea
sure
.
☐
☐
☐
F6.3
(c)(5
) • P
acka
ging
and
/or
labe
ling
batc
h re
cord
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for p
acka
ging
an
d/or
labe
ling
of b
atch
reco
rds t
hat i
nclu
de th
e da
te(s
) on
whi
ch, a
nd w
here
ap
plic
able
, the
tim
es a
t whi
ch, e
ach
step
of t
he p
acka
ging
and
/or l
abel
ing
prot
ocol
was
per
form
ed?
☐
☐
☐
SAMPLE
F6.3
(c)(6
) • P
acka
ging
and
/or
labe
ling
batc
h re
cord
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for p
acka
ging
an
d/or
labe
ling
of b
atch
reco
rds i
nclu
ding
the
iden
tity
of p
acka
ging
line
s and
m
ajor
equ
ipm
ent u
sed
in p
acka
ging
and
/or l
abel
ing
the
batc
h?
☐
☐
☐
F6.3
(c)(7
) • P
acka
ging
and
/or
labe
ling
batc
h re
cord
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for p
acka
ging
an
d/or
labe
ling
of b
atch
reco
rds i
nclu
ding
the
date
and
tim
e of
the
mai
nten
ance
, cle
anin
g, a
nd/o
r san
itizi
ng o
f the
pac
kagi
ng li
nes a
nd m
ajor
eq
uipm
ent u
sed
in p
acka
ging
and
labe
ling
of th
e ba
tch,
or a
cro
ss-r
efer
ence
to
reco
rds,
such
as i
ndiv
idua
l equ
ipm
ent l
ogs,
whe
re th
is in
form
atio
n is
re
cord
ed?
☐
☐
☐
F6.3
(c)(8
) • P
acka
ging
and
/or
labe
ling
batc
h re
cord
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for p
acka
ging
an
d/or
labe
ling
of b
atch
reco
rds,
incl
udin
g, if
pac
kagi
ng o
r lab
elin
g of
the
batc
h us
es e
quip
men
t or i
nstru
men
ts re
quiri
ng p
erio
dic
calib
ratio
n, in
spec
tion,
or
ver
ifica
tion,
the
date
and
tim
e of
the
last
cal
ibra
tion,
insp
ectio
n, o
r oth
er
verif
icat
ion
of in
stru
men
ts o
r equ
ipm
ent o
r the
dat
e on
whi
ch s
uch
is n
ext d
ue,
or a
cro
ss-r
efer
ence
to re
cord
s, su
ch a
s ind
ivid
ual e
quip
men
t log
s, w
here
this
in
form
atio
n is
reco
rded
?
☐
☐
☐
F6.3
(c)(9
) • P
acka
ging
and
/or
labe
ling
batc
h re
cord
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for p
acka
ging
an
d/or
labe
ling
of b
atch
reco
rds i
nclu
ding
a st
atem
ent o
f act
ual y
ield
and
a
stat
emen
t reg
ardi
ng w
heth
er th
e ac
tual
yie
ld is
with
in th
e ac
cept
able
rang
e of
th
e th
eore
tical
yie
ld a
s per
sect
ion
6.2(
a)(4
) at t
he e
nd o
f pac
kagi
ng a
nd/o
r la
belin
g?
☐
☐
☐
F6.3
(c)(1
0) •
Pack
agin
g an
d/or
labe
ling
batc
h re
cord
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for p
acka
ging
an
d/or
labe
ling
of b
atch
reco
rds i
nclu
ding
doc
umen
tatio
n fo
r whe
n th
e ac
tual
yi
eld
falls
out
side
the
allo
wed
lim
its, q
ualit
y-co
ntro
l per
sonn
el m
ust c
ondu
ct
an in
vest
igat
ion
of th
e ba
tch
and
dete
rmin
e, to
the
exte
nt p
ossi
ble,
the
sour
ce
of th
e di
scre
panc
y? T
he d
evia
tion
mus
t be
docu
men
ted,
exp
lain
ed, a
nd
appr
oved
by
qual
ity-c
ontro
l per
sonn
el.
☐
☐
☐
F6.3
(c)(1
1) •
Pack
agin
g an
d/or
labe
ling
batc
h re
cord
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for p
acka
ging
an
d/or
labe
ling
of b
atch
reco
rds i
nclu
ding
labe
l rec
onci
liatio
n, a
s per
sect
ion
6.3(
f) of
this
par
t?
☐
☐
☐
SAMPLE
F6.3
(c)(1
2) •
Pack
agin
g an
d/or
labe
ling
batc
h re
cord
- D
oes t
he o
pera
tion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for p
acka
ging
an
d/or
labe
ling
of b
atch
reco
rds i
nclu
ding
reco
rds o
f any
labe
ling
scra
p or
ca
nnab
is w
aste
gen
erat
ed d
urin
g pa
ckag
ing
and
/or l
abel
ing
of th
e ba
tch?
☐
☐
☐
F6.3
(c)(1
3)(i-
vi) •
Pac
kagi
ng a
nd/o
r la
belin
g ba
tch
reco
rd -
Doe
s the
op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for
pack
agin
g an
d/or
labe
ling
of b
atch
reco
rds,
incl
udin
g re
cord
s ide
ntify
ing
each
pe
rson
per
form
ing
each
pro
cess
step
in p
acka
ging
and
/or l
abel
ing
of th
e ba
tch?
Th
is in
clud
es b
ut is
not
lim
ited
to:
In
spec
ting
labe
ls a
nd o
ther
pac
kagi
ng c
ompo
nent
s to
ensu
re
suita
bilit
y an
d co
rrec
tnes
s prio
r to
use
in th
e ba
tch;
Insp
ectin
g pa
ckag
ing
and
labe
ling
area
s bef
ore
and
afte
r use
;
Rec
onci
ling
labe
l iss
uanc
e an
d us
age
and
verif
ying
the
reco
ncili
atio
n of
labe
l iss
uanc
e an
d us
age;
Exam
inin
g pa
ckag
ed a
nd la
bele
d pr
oduc
ts to
ens
ure
prop
er la
belin
g an
d co
ding
;
Perfo
rmin
g an
y ot
her c
heck
s or v
erifi
catio
ns in
pac
kagi
ng a
nd/o
r la
belin
g of
the
batc
h as
nee
ded;
and
Rel
easi
ng th
e ba
tch
from
one
stag
e of
pac
kagi
ng a
nd/o
r lab
elin
g to
th
e ne
xt.
☐
☐
☐
F6.3
(d) •
Pac
kagi
ng a
nd/o
r la
belin
g ba
tch
reco
rd -
Doe
s the
ope
ratio
n ha
ve
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for p
acka
ging
and
/or
labe
ling
of b
atch
reco
rds,
incl
udin
g th
e re
cord
ing
of a
ll da
ta, a
t the
tim
e at
w
hich
eac
h ac
tion
was
per
form
ed?
☐
☐
☐
F6.3
(e)(1
-2) •
Pac
kagi
ng a
nd/o
r la
belin
g ba
tch
reco
rd -
Doe
s the
ope
ratio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce fo
r pac
kagi
ng
and/
or la
belin
g of
bat
ch re
cord
s ens
urin
g th
at a
ll pr
intin
g de
vice
s loc
ated
on,
or
ass
ocia
ted
with
, pro
duct
ion
lines
are
mon
itore
d to
ass
ure
that
all
prin
ting
conf
orm
s to
the
requ
irem
ents
of t
he p
acka
ging
and
/or l
abel
ing
prot
ocol
use
d to
im
prin
t lab
elin
g or
cod
ing
dire
ctly
on
the
follo
win
g?
Pr
imar
y pa
ckag
ing
for t
he p
rodu
ct;
Se
cond
ary
pack
agin
g (e
.g.,
a ca
se c
onta
inin
g se
vera
l ind
ivid
ual
pack
ages
of p
rodu
ct).
☐
☐
☐
SAMPLE
F6.3
(f)(1
) • P
acka
ging
and
/or
labe
ling
batc
h re
cord
- D
oes t
he p
acka
ging
an
d la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
plac
e re
conc
iling
the
quan
titie
s of l
abel
s or l
abel
ing
issu
ed, u
sed,
and
retu
rned
to
stor
age,
that
est
ablis
hes n
arro
w li
mits
for t
he la
belin
g re
conc
iliat
ion
to b
e ba
sed,
whe
re p
ossi
ble,
on
histo
rical
ope
ratin
g da
ta, f
or th
e am
ount
of a
llow
ed
varia
tion
in th
e la
belin
g re
conc
iliat
ion?
☐
☐
☐
F6.3
(f)(2
) • P
acka
ging
and
/or
labe
ling
batc
h re
cord
- D
oes t
he p
acka
ging
an
d la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
plac
e re
conc
iling
whe
n la
belin
g fa
lls o
utsid
e th
e al
low
ed li
mits
such
that
qu
ality
-con
trol p
erso
nnel
mus
t con
duct
an
inve
stig
atio
n of
the
batc
h an
d de
term
ine,
to th
e ex
tent
pos
sibl
e, th
e so
urce
of t
he d
iscr
epan
cy?
The
dev
iatio
n m
ust b
e do
cum
ente
d, e
xpla
ined
, and
app
rove
d by
qua
lity-
cont
rol p
erso
nnel
.
☐
☐
☐
F6.3
(f)(3
) • P
acka
ging
and
/or
labe
ling
batc
h re
cord
- D
oes t
he p
acka
ging
an
d la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
plac
e do
cum
entin
g al
l rec
onci
liatio
n w
aive
d fo
r cut
or r
oll l
abel
s if a
100
%
exam
inat
ion
for c
orre
ct la
bels
has
bee
n pe
rform
ed, e
ither
man
ually
or b
y ap
prop
riate
ele
ctro
nic
or e
lect
rom
echa
nica
l equ
ipm
ent d
urin
g or
afte
r co
mpl
etio
n of
fini
shin
g op
erat
ions
?
☐
☐
☐
F6.3
(f)(4
) • P
acka
ging
and
/or
labe
ling
batc
h re
cord
- D
oes t
he p
acka
ging
an
d la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
plac
e re
quiri
ng a
ll ex
cess
labe
ling
bear
ing
batc
h, lo
t, or
con
trol n
umbe
rs b
e de
stro
yed?
☐
☐
☐
F6.3
(f)(5
) • P
acka
ging
and
/or
labe
ling
batc
h re
cord
- D
oes t
he p
acka
ging
an
d la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in
plac
e ou
tlini
ng th
e ca
re th
at m
ust b
e ta
ken
whe
n re
turn
ing
labe
ling
to st
orag
e,
to p
reve
nt m
ix-u
ps, a
nd e
nsur
ing
prop
er id
entif
icat
ion?
☐
☐
☐
F6.3
(g) •
Pac
kagi
ng a
nd/o
r la
belin
g ba
tch
reco
rd -
Doe
s the
pac
kagi
ng a
nd
labe
ling
oper
atio
n ha
ve w
ritte
n SO
Ps, p
roto
cols,
and
reco
rd k
eepi
ng in
pla
ce
iden
tifyi
ng re
pres
enta
tive
and
rese
rve
sam
ples
of e
ach
batc
h or
lot o
f ret
ail
pack
aged
and
/or l
abel
ed p
rodu
ct, a
s req
uire
d to
be
colle
cted
per
sect
ion
5.6
of
this
par
t?
☐
☐
☐
SAMPLE
F6.3
(h) •
Pac
kagi
ng a
nd/o
r la
belin
g ba
tch
reco
rd -
Doe
s the
pac
kagi
ng a
nd
labe
ling
oper
atio
n ha
ve w
ritte
n SO
Ps, p
roto
cols,
and
reco
rd k
eepi
ng in
pla
ce
notin
g th
e co
mpl
eted
pac
kagi
ng a
nd/o
r lab
elin
g ba
tch
reco
rd fo
r eac
h ba
tch
or
lot?
The
se re
cord
s muc
h be
revi
ewed
and
sign
ed b
y qu
ality
-con
trol p
erso
nnel
to
det
erm
ine
com
plia
nce
with
all
appl
icab
le sp
ecifi
catio
ns a
nd o
ther
re
quire
men
ts o
f the
pac
kagi
ng a
nd/o
r lab
elin
g pr
otoc
ol b
efor
e a
batc
h or
lot i
s ap
prov
ed.
☐
☐
☐
F6.3
(i) •
Pack
agin
g an
d/or
labe
ling
batc
h re
cord
- D
oes t
he p
acka
ging
and
la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
en
surin
g th
at p
acka
ged
or la
bele
d pr
oduc
ts th
at fa
il to
mee
t pac
kagi
ng o
r la
belin
g sp
ecifi
catio
ns o
r oth
er p
acka
ging
requ
irem
ents
are
reje
cted
, unl
ess
qual
ity-c
ontro
l per
sonn
el a
ppro
ve re
pack
agin
g, re
labe
ling,
or o
ther
dev
iatio
n th
at e
nsur
es th
e pr
oduc
t bat
ch o
r lot
will
mee
t all
pack
agin
g an
d la
belin
g sp
ecifi
catio
ns a
nd o
ther
pac
kagi
ng re
quire
men
ts, a
nd w
ill n
ot b
e ot
herw
ise
cont
amin
ated
or a
dulte
rate
d? A
ny su
ch re
pack
agin
g, re
labe
ling,
or o
ther
de
viat
ion
mus
t be
docu
men
ted,
just
ified
, and
app
rove
d by
qua
lity-
cont
rol
pers
onne
l.
☐
☐
☐
F6.4
(a)(
1-4)
• L
abel
con
tent
for
cann
abis
and
can
nabi
s-de
rive
d pr
oduc
ts -
Doe
s the
pac
kagi
ng a
nd la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
pac
kage
d or
labe
led
prod
ucts
bea
r on
the
labe
l of i
ts p
rimar
y pa
ckag
ing
the
nam
e an
d pl
ace
of b
usin
ess o
f the
m
anuf
actu
rer o
r dis
tribu
tor;
iden
tity
of th
e pr
oduc
t; ne
t qua
ntity
of c
onte
nts i
n te
rms o
f wei
ght,
num
eric
al c
ount
, or o
ther
app
ropr
iate
mea
sure
; and
a b
atch
, lo
t, or
con
trol n
umbe
r?
☐
☐
☐
F6.4
(a)(
5) •
Lab
el c
onte
nt fo
r ca
nnab
is a
nd c
anna
bis-
deri
ved
prod
ucts
- D
oes t
he p
acka
ging
and
labe
ling
oper
atio
n ha
ve w
ritte
n SO
Ps, p
roto
cols
, and
re
cord
kee
ping
in p
lace
ens
urin
g th
at p
acka
ged
or la
bele
d pr
oduc
ts b
ear o
n th
e la
bel o
f its
prim
ary
pack
agin
g ei
ther
a p
rodu
ctio
n da
te o
r an
expi
ratio
n da
te?
Pr
oduc
ts c
apab
le o
f sup
porti
ng th
e ra
pid
and
prog
ress
ive
grow
th o
f inf
ectio
us,
toxi
geni
c, o
r spo
ilage
mic
roor
gani
sms m
ust b
ear a
“us
e by
” da
te a
nd/o
r a
“fre
eze
by”
date
. Any
shel
f life
or e
xpira
tion
perio
d in
dica
ted
on th
e la
bel o
f an
edi
ble
prod
uct m
ust b
e su
ppor
ted
by a
ppro
pria
te d
ata.
☐
☐
☐
SAMPLE
F6.4
(a)(
6-9)
• L
abel
con
tent
for
cann
abis
and
can
nabi
s-de
rive
d pr
oduc
ts -
Doe
s the
pac
kagi
ng a
nd la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
pac
kage
d or
labe
led
prod
ucts
bea
r on
the
labe
l of i
ts p
rimar
y pa
ckag
ing
inst
ruct
ion
for u
se, i
nclu
ding
any
type
s of
com
plia
nt in
divi
dual
s for
who
m th
e pr
oduc
t is r
ecom
men
ded,
as a
ppro
pria
te;
inst
ruct
ions
for a
ppro
pria
te st
orag
e; a
nd a
ny o
ther
stat
emen
ts o
r inf
orm
atio
n re
quire
d by
stat
e re
gula
tors
?
☐
☐
☐
F6.4
(b)(
1-11
) • L
abel
con
tent
for
cann
abis
and
can
nabi
s-de
rive
d pr
oduc
ts
- Doe
s the
pac
kagi
ng a
nd la
belin
g op
erat
ion
have
writ
ten
SOPs
, pro
toco
ls, a
nd
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
pac
kage
d or
labe
led
prod
ucts
bea
r on
the
labe
l of p
rimar
y pa
ckag
ing
for a
ll ed
ible
pro
duct
s a “
Prod
uct F
acts
” bo
x lis
ting
quan
titat
ive
cont
ent a
nd n
utrie
nt in
form
atio
n re
leva
nt to
the
prod
uct,
incl
udin
g,
as a
pplic
able
, the
follo
win
g co
nten
t?
C
anna
bis i
ngre
dien
t;
Can
nabi
noid
and
/or t
erpe
noid
con
tent
;
Tota
l cal
orie
s and
fat c
alor
ies (
whe
n gr
eate
r tha
n 5
calo
ries p
er
serv
ing)
;
Tota
l fat
, sat
urat
ed fa
t, an
d tra
ns fa
t (w
hen
grea
ter t
han
0.5
g pe
r se
rvin
g);
C
hole
ster
ol (w
hen
grea
ter t
han
2 m
g pe
r ser
ving
);
Sodi
um (w
hen
grea
ter t
han
5 m
g pe
r ser
ving
);
Tota
l car
bohy
drat
es (w
hen
grea
ter t
han
1 g
per s
ervi
ng);
D
ieta
ry fi
ber (
whe
n gr
eate
r tha
n 1
g pe
r ser
ving
);
Suga
rs (w
hen
grea
ter t
han
1 g
per s
ervi
ng);
Pr
otei
n (w
hen
grea
ter t
han
1 g
per s
ervi
ng; a
nd
V
itam
in A
, vita
min
C, c
alci
um, a
nd ir
on (w
hen
pres
ent a
t gre
ater
th
an 2
% o
f the
reco
mm
ende
d da
ily in
take
).
☐
☐
☐
G7.
1(a)
(1-3
) • Id
entif
icat
ion
- Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
the
prop
er id
entif
icat
ion,
at a
ll tim
es, o
f eac
h co
ntai
ner o
f com
pone
nt, p
acka
ging
com
pone
nt, i
n-pr
oces
s mat
eria
l, an
d pr
oduc
t, in
clud
ing
the
follo
win
g?
Id
entit
y of
the
item
;
Bat
ch, l
ot, o
r con
trol n
umbe
r;
Stat
us (e
.g.,
quar
antin
ed, a
ppro
ved,
reca
lled,
reje
cted
).
☐
☐
☐
SAMPLE
G7.
1(b)
• Id
entif
icat
ion
- Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
the
prop
er id
entif
icat
ion
and
hand
ling
of
prod
uct p
acka
ges t
hat a
re h
eld
in u
nlab
eled
con
ditio
n fo
r fut
ure
labe
ling
oper
atio
n, p
recl
udin
g m
isla
belin
g of
indi
vidu
al c
onta
iner
s, lo
ts, o
r bat
ches
?
Iden
tific
atio
n ne
ed n
ot b
e ap
plie
d to
eac
h in
divi
dual
con
tain
er b
ut m
ust b
e su
ffici
ent t
o de
term
ine
the
iden
tity
of th
e pr
oduc
t, qu
antit
y of
con
tent
s, an
d ba
tch,
lot,
or c
ontro
l num
ber o
f eac
h co
ntai
ner.
☐
☐
☐
G7.
1(c)
(1-2
) • Id
entif
icat
ion
- Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
the
iden
tific
atio
n in
form
atio
n re
quire
d in
se
ctio
n 7.
1(a)
and
(b) h
as b
een
affix
ed to
the
indi
vidu
al c
onta
iner
or t
o an
ap
prop
riate
gro
upin
g of
con
tain
ers,
or a
ssig
ned
to th
e ro
om o
r oth
er d
efin
ed
phys
ical
loca
tion
of th
e co
ntai
ner(
s)?
☐
☐
☐
G7.
2(a)
• St
orag
e an
d ha
ndlin
g - D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, an
d re
cord
kee
ping
in p
lace
ens
urin
g th
at a
ll co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, and
pro
duct
s are
, at a
ll tim
es, h
andl
ed,
stor
ed, a
nd d
istri
bute
d in
a m
anne
r to
avoi
d de
terio
ratio
n, p
reve
nt
cont
amin
atio
n, a
nd m
ix-u
ps?
Whe
re n
eces
sary
, are
app
ropr
iate
con
ditio
ns o
f te
mpe
ratu
re, h
umid
ity, a
nd li
ght e
stab
lishe
d an
d m
aint
aine
d so
that
the
iden
tity,
pur
ity, s
treng
th, a
nd c
ompo
sitio
n of
com
pone
nts,
in-p
roce
ss m
ater
ials
, an
d pr
oduc
ts a
re n
ot a
ffect
ed a
nd th
at a
dulte
ratio
n is
pre
vent
ed, a
s req
uire
d?
☐
☐
☐
G7.
2(b)
• St
orag
e an
d ha
ndlin
g - D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, an
d re
cord
kee
ping
in p
lace
ens
urin
g th
at a
ll co
ntai
ners
of c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
and
pro
duct
are
pro
perly
stor
ed
off t
he fl
oor a
nd su
itabl
y sp
aced
to p
erm
it cl
eani
ng a
nd in
spec
tion?
☐
☐
☐
G7.
2(c)
• St
orag
e an
d ha
ndlin
g - D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, an
d re
cord
kee
ping
in p
lace
ens
urin
g th
at a
ll co
mpo
nent
s, in
-pro
cess
mat
eria
ls,
and
prod
ucts
that
can
supp
ort t
he ra
pid
grow
th o
f mic
roor
gani
sms o
f pub
lic
heal
th si
gnifi
canc
e ar
e he
ld in
a m
anne
r tha
t pre
vent
s the
m fr
om b
ecom
ing
adul
tera
ted?
☐
☐
☐
G7.
2(d)
• St
orag
e an
d ha
ndlin
g - D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, an
d re
cord
kee
ping
in p
lace
ens
urin
g th
at a
ll la
bels
, lab
elin
g, c
anna
bis,
cann
abis
-der
ived
pro
duct
s, an
d ca
nnab
is w
aste
are
stor
ed in
a c
ontro
lled
acce
ss
area
?
☐
☐
☐
SAMPLE
G7.
2(e)
• St
orag
e an
d ha
ndlin
g - D
oes t
he o
pera
tion
have
SO
Ps, p
roto
cols
, an
d re
cord
kee
ping
in p
lace
ens
urin
g th
at a
ll co
mpo
nent
s, pa
ckag
ing
com
pone
nts,
and
prod
ucts
are
use
d or
dis
tribu
ted
in a
man
ner w
here
by th
e ol
dest
bat
ches
or l
ots a
re u
sed
or d
istri
bute
d fir
st?
Dev
iatio
n fro
m th
is
requ
irem
ent i
s per
mitt
ed if
such
dev
iatio
n is
tem
pora
ry a
nd a
ppro
pria
te.
☐
☐
☐
G7.
3(a)
(1-5
) • W
ithho
ldin
g m
ater
ials
from
use
or
dist
ribu
tion
- Doe
s the
m
anuf
actu
ring,
pac
kagi
ng, a
nd la
belin
g op
erat
ion
have
SO
Ps, p
roto
cols
, and
re
cord
kee
ping
in p
lace
ens
urin
g th
e ab
ility
to q
uara
ntin
e an
y lo
t, ba
tch,
or
othe
r por
tion
of c
ompo
nent
, pac
kagi
ng c
ompo
nent
, in-
proc
ess m
ater
ial,
or
prod
uct w
hose
suita
bilit
y fo
r use
or d
istri
butio
n is
in q
uest
ion,
to p
reve
nt it
s us
e an
d di
strib
utio
n pe
ndin
g di
spos
ition
by
qual
ity-c
ontro
l per
sonn
el,
incl
udin
g th
e fo
llow
ing?
New
ly re
ceiv
ed c
ompo
nent
s and
pac
kagi
ng c
ompo
nent
s for
use
in
man
ufac
turin
g, p
acka
ging
, and
/or l
abel
ing;
Bat
ches
new
ly c
ompl
eted
in p
rodu
ctio
n;
Pr
oduc
t ret
urne
d to
the
oper
atio
n fo
r any
reas
on;
C
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, or
prod
ucts
that
are
or m
ay b
e co
ntam
inat
ed o
r adu
ltera
ted;
Com
pone
nts,
pack
agin
g co
mpo
nent
s, in
-pro
cess
mat
eria
l or p
rodu
cts
that
are
und
er in
vest
igat
ion
by q
ualit
y-co
ntro
l per
sonn
el fo
r any
ot
her r
easo
n.
☐
☐
☐
G7.
3(b)
• W
ithho
ldin
g m
ater
ials
from
use
or
dist
ribu
tion
- Doe
s the
op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
re
ject
ed c
ompo
nent
s, pa
ckag
ing
com
pone
nts,
in-p
roce
ss m
ater
ials
, fin
ishe
d pr
oduc
t, ca
nnab
is w
aste
, and
reje
cted
labe
ls a
nd la
belin
g (in
clud
ing
any
exce
ss
labe
ling
bear
ing
lot,
batc
h, o
r con
trol n
umbe
rs w
hich
is n
ot im
med
iate
ly
dest
roye
d af
ter p
acka
ging
ope
ratio
ns a
re c
ompl
ete)
will
be
appr
opria
tely
se
greg
ated
, con
trolle
d, a
nd h
eld
in a
con
trolle
d-ac
cess
are
a pe
ndin
g de
stru
ctio
n or
oth
er d
ispo
sal?
☐
☐
☐
G7.
3(c)
• W
ithho
ldin
g m
ater
ials
from
use
or
dist
ribu
tion
- Doe
s the
op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce e
nsur
ing
that
ca
nnab
is w
aste
(oth
er th
an c
anna
bis a
nd c
anna
bis-
deriv
ed p
rodu
ct th
at h
as
been
reje
cted
and
retu
rned
to th
e ve
ndor
) and
reje
cted
labe
ls a
nd o
ther
labe
ling
are
dest
roye
d in
a m
anne
r whi
ch p
reve
nts u
naut
horiz
ed u
se?
Is d
estru
ctio
n of
an
y ca
nnab
is w
aste
doc
umen
ted
and
witn
esse
d by
at l
east
two
wor
kers
, one
of
who
m m
ust b
e su
perv
isor
y, m
anag
eria
l, or
qua
lity-
cont
rol p
erso
nnel
, unl
ess
vide
o su
rvei
llanc
e is
use
d, in
whi
ch c
ase
only
one
wor
ker i
s nec
essa
ry, a
s re
quire
d? D
estru
ctio
n m
ay in
clud
e co
mpo
stin
g.
☐
☐
☐
SAMPLE
H8.
1(a)
• M
ater
ials
inve
ntor
y - D
oes t
he m
anuf
actu
ring,
pac
kagi
ng, l
abel
ing,
an
d ho
ldin
g op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng fo
r eac
h sh
ipm
ent o
f com
pone
nt, p
acka
ging
com
pone
nt, c
anna
bis,
and
cann
abis
-de
rived
pro
duct
rece
ived
from
ano
ther
com
pany
or i
ndiv
idua
l?
☐
☐
☐
H8.
1(b)
(1-2
) • M
ater
ials
inve
ntor
y - D
oes t
he m
anuf
actu
ring,
pac
kagi
ng,
labe
ling,
and
hol
ding
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
no
ting
the
iden
tity
of th
e re
ceiv
ed it
em, a
s app
licab
le to
the
item
; any
co
mpo
nent
num
ber o
r pro
duct
num
ber i
f suc
h ar
e in
use
be
the
supp
lier;
and
the
supp
lier o
r ven
dor f
rom
whi
ch th
e sh
ipm
ent w
as re
ceiv
ed?
☐
☐
☐
H8.
1(b)
(3-6
) • M
ater
ials
inve
ntor
y - D
oes t
he m
anuf
actu
ring,
pac
kagi
ng,
labe
ling,
and
hol
ding
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
ev
iden
ce n
otin
g th
e fo
llow
ing
info
rmat
ion?
The
orig
inal
cul
tivat
ion
oper
atio
n, p
roce
ssin
g op
erat
ion,
or
man
ufac
turin
g op
erat
ion,
if k
now
n an
d w
here
app
licab
le;
Th
e cu
ltiva
tion
oper
atio
n, p
roce
ssin
g op
erat
ion,
man
ufac
turin
g op
erat
ion,
or s
uppl
ier’
s bat
ch, l
ot o
r con
trol n
umbe
r, if
know
n an
d w
here
app
licab
le;
D
ate
of re
ceip
t; an
d
Ship
men
t del
iver
y m
etho
d, in
clud
ing
whe
re a
pplic
able
, the
nam
e of
th
e co
mm
erci
al o
r priv
ate
carr
ier.
☐
☐
☐
H8.
1(c)
(1) •
Mat
eria
ls in
vent
ory
- Doe
s the
man
ufac
turin
g, p
acka
ging
, and
la
belin
g op
erat
ion
have
SO
Ps a
nd p
roto
cols
, for
the
reco
rd k
eepi
ng o
r es
tabl
ishm
ent o
f cro
ss re
fere
nces
to o
ther
reco
rds s
uch
as m
anuf
actu
ring
batc
h re
cord
s inc
ludi
ng th
e ba
tch,
lot,
or o
ther
con
trol n
umbe
r ass
igne
d by
the
man
ufac
turin
g, p
acka
ging
, and
/or l
abel
ing
oper
atio
n to
the
ship
men
t?
☐
☐
☐
H8.
1(c)
(2) •
Mat
eria
ls in
vent
ory
- Doe
s the
man
ufac
turin
g, p
acka
ging
, and
la
belin
g op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng, o
r hav
e es
tabl
ishe
d cr
oss r
efer
ence
syst
ems t
o ot
her r
ecor
ds su
ch a
s man
ufac
turin
g ba
tch
reco
rds,
reco
rdin
g th
e in
spec
tion,
sam
plin
g, te
stin
g an
d ex
amin
atio
ns
perfo
rmed
on
the
batc
h or
lot,
and
the
conc
lusi
ons d
eriv
ed th
ere
from
, as
appl
icab
le to
the
scop
e of
the
oper
atio
n?
☐
☐
☐
SAMPLE
H8.
1(c)
(3) •
Mat
eria
ls in
vent
ory
- Doe
s the
man
ufac
turin
g, p
acka
ging
, and
la
belin
g op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng, o
r hav
e
esta
blis
hed
cros
s ref
eren
ce sy
stem
s to
othe
r rec
ords
such
as m
anuf
actu
ring
batc
h re
cord
s, re
cord
ing
all t
reat
men
t, re
proc
essi
ng, o
r oth
er d
evia
tion
perfo
rmed
by
the
oper
atio
n on
the
batc
h or
lot p
rior t
o us
e?
☐
☐
☐
H8.
1(c)
(4) •
Mat
eria
ls in
vent
ory
- Doe
s the
man
ufac
turin
g, p
acka
ging
, and
la
belin
g op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng, o
r hav
e es
tabl
ishe
d cr
oss r
efer
ence
syst
ems t
o ot
her r
ecor
ds su
ch a
s man
ufac
turin
g ba
tch
reco
rds,
reco
rdin
g th
e di
spos
ition
of t
he b
atch
or l
ot b
y qu
ality
-con
trol
pers
onne
l, in
clud
ing
the
date
and
sign
atur
e of
the
pers
on re
spon
sibl
e fo
r ap
prov
ing
or re
ject
ing
the
batc
h or
lot a
nd a
ny tr
eatm
ents
, rep
roce
ssin
g, o
r ot
her d
evia
tion
perfo
rmed
ther
eon?
☐
☐
☐
H8.
1(c)
(5)(
i-iii)
• M
ater
ials
inve
ntor
y - D
oes t
he m
anuf
actu
ring,
pac
kagi
ng,
and
labe
ling
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
, or h
ave
esta
blis
hed
cros
s ref
eren
ce sy
stem
s to
othe
r rec
ords
such
as m
anuf
actu
ring
batc
h re
cord
s, no
ting
each
use
of t
he b
atch
or l
ot in
pro
duct
ion,
incl
udin
g th
e qu
antit
y us
ed, i
nclu
ding
uni
t of m
easu
re; n
ame
and
batc
h, lo
t or o
ther
con
trol
num
ber o
f the
pro
duct
bat
ch in
whi
ch th
e ba
tch
or lo
t is u
sed,
and
the
initi
als
of th
e pe
rson
(s) r
espo
nsib
le fo
r rem
ovin
g fro
m st
orag
e th
e ne
cess
ary
quan
tity
for u
se in
the
desi
gnat
ed b
atch
?
☐
☐
☐
H8.
1(c)
(6)(
i-iii)
• M
ater
ials
inve
ntor
y - D
oes t
he m
anuf
actu
ring,
pac
kagi
ng,
and
labe
ling
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
, or h
ave
esta
blis
hed
cros
s ref
eren
ce sy
stem
s to
othe
r rec
ords
such
as m
anuf
actu
ring
batc
h re
cord
s, no
ting
a re
cord
of a
ny p
ortio
n of
the
batc
h or
lot r
etur
ned
from
pr
oduc
tion
to st
orag
e in
clud
ing
the
quan
tity
retu
rned
; uni
t of m
easu
re; n
ame
and
batc
h, lo
t, or
oth
er c
ontro
l num
ber o
f the
bat
ch o
r lot
from
whi
ch th
e po
rtion
is re
turn
ed; a
nd th
e in
itial
s of t
he p
erso
ns re
spon
sibl
e fo
r ver
ifyin
g th
e qu
antit
y re
turn
ed?
☐
☐
☐
H8.
1(c)
(7)(
i-iii)
• M
ater
ials
inve
ntor
y - D
oes t
he m
anuf
actu
ring,
pac
kagi
ng,
and
labe
ling
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
, or h
ave
esta
blis
hed
cros
s ref
eren
ce sy
stem
s to
othe
r rec
ords
such
as m
anuf
actu
ring
batc
h re
cord
s, in
clud
ing
a re
cord
of a
ny p
ortio
n of
the
batc
h or
lot d
ispo
sed
of
from
stor
age,
incl
udin
g th
e qu
antit
y, u
nit o
f mea
sure
, rea
son,
and
per
sons
re
spon
sible
for m
easu
ring
the
quan
tity?
☐
☐
☐
SAMPLE
H8.
2(a)
• D
istr
ibut
ed m
ater
ials
- D
oes t
he m
anuf
actu
ring,
pac
kagi
ng,
labe
ling,
and
hol
ding
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
for
each
bat
ch o
r lot
of c
anna
bis o
r can
nabi
s-de
rived
pro
duct
dis
tribu
ted
by th
e op
erat
ion?
☐
☐
☐
H8.
2(b)
(1) •
Dis
trib
uted
mat
eria
ls -
Doe
s the
man
ufac
turin
g, p
acka
ging
, la
belin
g, a
nd h
oldi
ng o
pera
tion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng th
at
incl
udes
the
iden
tity
of th
e ca
nnab
is o
r can
nabi
s-de
rived
pro
duct
and
any
item
co
de o
r pro
duct
num
ber,
if su
ch a
re in
use
by
the
man
ufac
turin
g, p
acka
ging
, la
belin
g, o
r hol
ding
ope
ratio
n?
☐
☐
☐
H8.
2(b)
(2)(
i-iv)
• D
istr
ibut
ed m
ater
ials
- D
oes t
he m
anuf
actu
ring,
pa
ckag
ing,
labe
ling,
and
hol
ding
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
ke
epin
g th
at in
clud
es a
reco
rd o
f eac
h di
strib
utio
n of
the
batc
h or
lot,
incl
udin
g th
e fo
llow
ing?
Qua
ntity
dis
tribu
ted,
incl
udin
g un
it of
mea
sure
;
Nam
e an
d ad
dres
s of e
ach
com
pany
or n
on-p
rofit
ent
ity to
whi
ch, o
r in
divi
dual
to w
hom
, the
bat
ch is
dis
tribu
ted,
unl
ess a
syst
em e
xist
s to
unam
bigu
ousl
y cr
oss-
refe
renc
e th
e na
me
to th
e co
rres
pond
ing
addr
ess m
aint
aine
d on
file
sepa
rate
ly;
Sh
ippi
ng m
etho
d by
whi
ch e
ach
ship
men
t is d
istri
bute
d, in
clud
ing
whe
re a
pplic
able
the
nam
e of
the
com
mer
cial
or p
rivat
e ca
rrie
r;
Initi
als o
f the
per
sons
resp
onsib
le fo
r rem
ovin
g fro
m st
orag
e th
e ne
cess
ary
quan
tity
for e
ach
ship
men
t. Ea
ch d
istri
butio
n m
ust b
e ve
rifie
d by
a se
cond
per
son
☐
☐
☐
H8.
2(b)
(3)(
i-iv)
• D
istr
ibut
ed m
ater
ials
- D
oes t
he m
anuf
actu
ring,
pa
ckag
ing,
labe
ling,
and
hol
ding
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
ke
epin
g th
at in
clud
es a
reco
rd o
f any
por
tion
of th
e ba
tch
or lo
t ret
urne
d to
st
orag
e, in
clud
ing
the
follo
win
g?
Q
uant
ity re
turn
ed, i
nclu
ding
the
unit
of m
easu
re;
C
ompa
ny, n
on-p
rofit
ent
ity, i
ndiv
idua
l, or
loca
tion
from
whi
ch th
e po
rtion
is re
turn
ed;
Sh
ipm
ent r
etur
n m
etho
d, in
clud
ing
whe
re a
pplic
able
the
nam
e of
the
com
mer
cial
or p
rivat
e ca
rrie
r;
Initi
als o
f the
per
son(
s) re
spon
sible
for v
erify
ing
the
quan
tity
retu
rned
.
☐
☐
☐
SAMPLE
H8.
2(c)
(1-4
) • D
istr
ibut
ed m
ater
ials
- D
oes t
he m
anuf
actu
ring,
pac
kagi
ng,
labe
ling,
and
hol
ding
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
, or
esta
blis
hed
the
abili
ty to
cro
ss re
fere
nce
to o
ther
reco
rds s
uch
as
man
ufac
turin
g ba
tch
reco
rds,
for t
he fo
llow
ing?
Bat
ch, l
ot, o
r oth
er c
ontro
l num
ber a
ssig
ned
by th
e m
anuf
actu
ring,
pa
ckag
ing,
and
/or l
abel
ing
oper
atio
n to
the
batc
h or
lot;
In
spec
tion,
sam
plin
g, te
stin
g, a
nd e
xam
inat
ions
per
form
ed o
n th
e ba
tch
or lo
t by
the
oper
atio
n, a
nd th
e co
nclu
sion
s der
ived
ther
e fro
m;
A
ny tr
eatm
ent,
repr
oces
sing
, or o
ther
dev
iatio
n pe
rform
ed o
n th
e ba
tch
or lo
t by
the
oper
atio
n pr
ior t
o di
strib
utio
n;
D
ispo
sitio
n of
the
batc
h or
lot b
y qu
ality
-con
trol p
erso
nnel
, in
clud
ing
the
date
and
the
sign
atur
e of
the
pers
on re
spon
sibl
e fo
r the
ap
prov
ing
the
batc
h or
lot f
or d
istri
butio
n; a
nd
Th
e da
te a
nd th
e si
gnat
ure
of th
e pe
rson
resp
onsib
le fo
r app
rovi
ng o
r re
ject
ing
ay tr
eatm
ent,
repr
oces
sing,
or o
ther
dev
iatio
n pe
rform
ed
ther
eon.
☐
☐
☐
H8.
4(a)
• R
econ
cilia
tion
- Doe
s the
ope
ratio
n ha
ve S
OPs
, pro
toco
ls, a
nd
reco
rd k
eepi
ng fo
r rec
ords
of r
ecei
pt, u
se o
r dis
tribu
tion,
retu
rn, a
nd d
ispos
al
of e
ach
batc
h or
lot o
f com
pone
nts,
pack
agin
g co
mpo
nent
s, ca
nnab
is o
r ca
nnab
is-d
eriv
ed p
rodu
cts t
o be
kep
t chr
onol
ogic
ally
, and
the
quan
titie
s mus
t be
reco
rded
with
an
appr
opria
te le
vel o
f pre
cisi
on?
☐
☐
☐
H8.
4(b)
• R
econ
cilia
tion
- Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, a
nd
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at a
fter e
ach
batc
h or
lot i
s use
d or
dis
tribu
ted
a re
conc
iliat
ion
of th
e qu
antit
y re
ceiv
ed in
to st
orag
e ag
ains
t the
qua
ntity
use
d, d
istri
bute
d, re
turn
ed, a
nd/o
r di
spos
ed c
an b
e as
sess
ed?
Are
such
cal
cula
tions
per
form
ed b
y on
e pe
rson
and
in
depe
nden
tly v
erifi
ed b
y a
seco
nd p
erso
n, a
s req
uire
d?
☐
☐
☐
H8.
4(c)
• R
econ
cilia
tion
- Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, a
nd
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at n
arro
w li
mits
are
est
ablis
hed,
bas
ed w
here
pos
sibl
e on
his
toric
al o
pera
ting
data
, for
the
amou
nt o
f allo
wed
var
iatio
n in
the
reco
ncili
atio
n?
☐
☐
☐
H8.
4(d)
• R
econ
cilia
tion
- Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, a
nd
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at w
hen
a re
conc
iliat
ion
falls
out
side
the
allo
wed
lim
its, q
ualit
y-co
ntro
l pe
rson
nel w
ill c
ondu
ct a
n in
vest
igat
ion
to d
eter
min
e, to
the
exte
nt p
ossi
ble,
the
sour
ce o
f the
dis
crep
ancy
? T
he d
evia
tion
mus
t be
docu
men
ted,
exp
lain
ed, a
nd
appr
oved
by
qual
ity-c
ontro
l per
sonn
el.
☐
☐
☐
SAMPLE
H8.
5(a)
• R
ecor
d re
tent
ion
- Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g,
and
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
en
surin
g th
at, e
xcep
t as r
equi
red
in se
ctio
ns 8
.5(b
) and
(c),
the
oper
atio
n re
tain
s the
reco
rds r
equi
red
by th
is pa
rt fo
r a p
erio
d of
at l
east
thre
e ye
ars p
ast
date
of c
reat
ion
of th
e re
cord
, or o
ne y
ear p
ast t
he e
xpira
tion
date
of t
he re
late
d pr
oduc
t, w
hich
ever
is lo
nger
, as a
pplic
able
to th
e op
erat
ion?
☐
☐
☐
H8.
5(b)
• R
ecor
d re
tent
ion
- Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g,
and
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
en
surin
g th
at p
rodu
ct c
ompl
aint
reco
rds a
re re
tain
ed fo
r one
yea
r pas
t the
ex
pira
tion
date
of t
he b
atch
or l
ot a
ffec
ted,
or f
or o
ne y
ear p
ast t
he d
ate
of
rece
ipt o
f the
com
plai
nt, w
hich
ever
is lo
nger
?
☐
☐
☐
H8.
5(c)
• R
ecor
d re
tent
ion
- Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g,
and
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
en
surin
g th
at re
cord
s for
retu
rned
pro
duct
s ar
e re
tain
ed fo
r one
yea
r pas
t the
ex
pira
tion
date
of t
he b
atch
or l
ot a
ffec
ted,
or f
or o
ne y
ear p
ast t
he d
ate
of
rece
ipt o
f the
retu
rn, w
hich
ever
is lo
nger
?
☐
☐
☐
I9.1
(a) •
Com
plai
nt fi
les -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, a
nd
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
de
scrib
ing
the
hand
ling
of p
rodu
ct c
ompl
aint
s rec
eive
d re
gard
ing
a ca
nnab
is o
r ca
nnab
is-d
eriv
ed p
rodu
ct?
☐
☐
☐
I9.1
(b)(
1-2)
• C
ompl
aint
file
s - D
oes t
he m
anuf
actu
ring,
pac
kagi
ng, l
abel
ing,
an
d ho
ldin
g op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng in
pla
ce
requ
iring
a q
ualif
ied
pers
on to
do
the
follo
win
g?
R
evie
w p
rodu
ct c
ompl
aint
s to
dete
rmin
e w
heth
er th
e pr
oduc
t co
mpl
aint
invo
lves
a p
ossib
le fa
ilure
of a
pro
duct
to m
eet a
ny o
f its
sp
ecifi
catio
ns, o
r any
oth
er re
quire
men
ts, i
nclu
ding
but
not
lim
ited
to
thos
e sp
ecifi
catio
ns a
nd o
ther
requ
irem
ents
that
, if n
ot m
et, m
ay
resu
lt in
a ri
sk o
f illn
ess o
r inj
ury;
and
Inve
stig
ate
any
prod
uct c
ompl
aint
that
invo
lves
a p
ossi
ble
failu
re o
f a
prod
uct t
o m
eet a
ny o
f its
spec
ifica
tions
, or a
ny o
ther
requ
irem
ents
of
this
par
t, in
clud
ing
but n
ot li
mite
d to
thos
e sp
ecifi
catio
ns a
nd
othe
r req
uire
men
ts th
at, i
f not
met
, may
resu
lt in
a ri
sk o
f illn
ess o
r in
jury
.
☐
☐
☐
SAMPLE
I9.1
(c) •
Com
plai
nt fi
les -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, a
nd
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
at q
ualit
y-co
ntro
l per
sonn
el re
view
and
app
rove
dec
isio
ns a
bout
whe
ther
to
inve
stig
ate
a pr
oduc
t com
plai
nt a
nd re
view
and
app
rove
the
findi
ngs a
nd
follo
w-u
p ac
tion
of a
ny in
vest
igat
ion
perfo
rmed
?
☐
☐
☐
I9.1
(d) •
Com
plai
nt fi
les -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, a
nd
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
ens
urin
g th
e re
view
and
inve
stig
atio
n of
the
prod
uct c
ompl
aint
, and
the
revi
ew b
y qu
ality
-con
trol p
erso
nnel
abo
ut w
heth
er to
inve
stig
ate
a pr
oduc
t com
plai
nt,
and
the
findi
ngs a
nd fo
llow
-up
actio
n of
any
inve
stig
atio
n pe
rform
ed, e
xten
ds
to a
ll re
late
d ba
tche
s and
rele
vant
reco
rds?
Rel
ated
bat
ches
may
incl
ude,
but
ar
e no
t lim
ited
to, b
atch
es o
f the
sam
e pr
oduc
t, ot
her b
atch
es p
roce
ssed
on
the
sam
e eq
uipm
ent o
r dur
ing
the
sam
e tim
e pe
riod,
or o
ther
bat
ches
pro
duce
d us
ing
the
sam
e ba
tche
s or l
ots o
f com
pone
nts o
r pac
kagi
ng c
ompo
nent
s.
☐
☐
☐
I9.1
(e) •
Com
plai
nt fi
les -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, a
nd
hold
ing
oper
atio
n ha
ve a
writ
ten
reco
rd o
f the
com
plai
nt(s
) and
whe
re
appl
icab
le it
s inv
estig
atio
n re
port,
to in
clud
e th
e fo
llow
ing
info
rmat
ion?
Iden
tity
of th
e pr
oduc
t;
Bat
ch, l
ot o
r oth
er c
ontro
l num
ber o
f the
pro
duct
;
Dat
e th
e co
mpl
aint
was
rece
ived
and
the
nam
e, a
ddre
ss, o
r tel
epho
ne
num
ber o
f the
com
plai
nant
, if a
vaila
ble;
Nat
ure
of th
e co
mpl
aint
incl
udin
g, if
kno
wn,
how
the
prod
uct w
as
used
Nam
es o
f per
sonn
el w
ho d
o th
e fo
llow
ing;
revi
ew a
nd a
ppro
ve th
e de
cisi
on a
bout
whe
ther
to in
vest
igat
e a
prod
uct c
ompl
aint
s;
inve
stig
ate
the
com
plai
nt; a
nd re
view
and
app
rove
the
findi
ngs a
nd
follo
w-u
p ac
tion
of a
ny in
vest
igat
ion
perfo
rmed
;
Find
ings
of t
he in
vest
igat
ion
and
follo
w-u
p ac
tion
take
n w
hen
an
inve
stig
atio
n is
per
form
ed; a
nd
R
espo
nse
to th
e co
mpl
aina
nt, i
f app
licab
le.
☐
☐
☐
SAMPLE
I9.1
(f) •
Com
plai
nt fi
les -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g, a
nd
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
for a
pr
oduc
t com
plai
nt th
at in
clud
es a
repo
rt of
an
adve
rse
even
t? F
or p
urpo
ses o
f th
is se
ctio
n, a
n ad
vers
e ev
ent i
s a h
ealth
-rel
ated
eve
nt a
ssoc
iate
d w
ith u
se o
f a
prod
uct t
hat i
s und
esira
ble,
and
that
is u
nexp
ecte
d or
unu
sual
. The
pro
cedu
re
mus
t add
ress
whe
ther
the
adve
rse
even
t req
uire
s the
follo
win
g:
R
epor
ting
to a
ny p
ublic
hea
lth a
utho
rity;
Rep
ortin
g to
the
phys
icia
n of
reco
rd fo
r the
indi
vidu
al re
porte
d to
ha
ve e
xper
ienc
ed th
e ad
vers
e ev
ent,
if kn
own;
and
Prod
uct r
ecal
l.
☐
☐
☐
I9.2
(a) •
Ret
urne
d pr
oduc
ts -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g,
and
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
de
scrib
ing
the
rece
ipt,
hand
ling,
and
dis
posi
tion
of re
turn
ed c
anna
bis o
r ca
nnab
is-d
eriv
ed p
rodu
cts?
☐
☐
☐
I9.2
(b) •
Ret
urne
d pr
oduc
ts -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g,
and
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
en
surin
g th
at re
turn
ed p
rodu
cts a
re p
rope
rly id
entif
ied
as su
ch a
nd q
uara
ntin
ed
upon
rece
ipt?
☐
☐
☐
I9.2
(c) •
Ret
urne
d pr
oduc
ts -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g,
and
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
en
surin
g re
turn
ed p
rodu
ct is
revi
ewed
and
app
rove
d or
reje
cted
by
qual
ity-
cont
rol p
erso
nnel
?
☐
☐
☐
I9.2
(d) •
Ret
urne
d pr
oduc
ts -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g,
and
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
en
surin
g th
at if
the
cond
ition
s und
er w
hich
retu
rned
pro
duct
has
bee
n he
ld,
stor
ed, o
r shi
pped
bef
ore
or d
urin
g its
retu
rn, o
r if t
he c
ondi
tion
of th
e pr
oduc
t, its
con
tain
ers,
or la
belin
g, a
s a re
sult
of st
orag
e or
ship
ping
, cas
ts d
oubt
on
the
iden
tity,
pur
ity, s
treng
th, c
ompo
sitio
n, o
r fre
edom
from
con
tam
inat
ion
or
adul
tera
tion
of th
e pr
oduc
t, th
e re
turn
ed p
rodu
ct sh
all b
e re
ject
ed u
nles
s ex
amin
atio
n, te
stin
g, o
r oth
er in
vest
igat
ions
pro
ve th
e pr
oduc
t mee
ts
appr
opria
te st
anda
rds o
f ide
ntity
, pur
ity, s
treng
th, a
nd c
ompo
sitio
n an
d its
fre
edom
from
con
tam
inat
ion
or a
dulte
ratio
n?
☐
☐
☐
SAMPLE
I9.2
(e) •
Ret
urne
d pr
oduc
ts -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g,
and
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
en
surin
g th
at if
the
reas
on a
pro
duct
is re
turn
ed im
plic
ates
ass
ocia
ted
batc
hes,
an a
ppro
pria
te in
vest
igat
ion
is c
ondu
cted
that
ext
ends
to a
ll re
late
d ba
tche
s and
re
leva
nt re
cord
s? R
elat
ed b
atch
es m
ay in
clud
e, b
ut a
re n
ot li
mite
d to
, bat
ches
of
the
sam
e pr
oduc
t, ot
her b
atch
es p
roce
ssed
on
the
sam
e eq
uipm
ent o
r dur
ing
the
sam
e tim
e pe
riod,
or o
ther
bat
ches
pro
duce
d us
ing
the
sam
e co
mpo
nent
s or
pack
agin
g co
mpo
nent
s.
☐
☐
☐
I9.2
(f) •
Ret
urne
d pr
oduc
ts -
Doe
s the
man
ufac
turin
g, p
acka
ging
, lab
elin
g,
and
hold
ing
oper
atio
n ha
ve S
OPs
, pro
toco
ls, a
nd re
cord
kee
ping
in p
lace
en
surin
g th
e de
stru
ctio
n, a
s per
sect
ion
7.3(
c), o
f rej
ecte
d re
turn
ed p
rodu
ct
retu
rned
to th
e op
erat
ion?
☐
☐
☐
I9.2
(g)(
1-10
) • R
etur
ned
prod
ucts
- D
oes t
he m
anuf
actu
ring,
pac
kagi
ng,
labe
ling,
and
hol
ding
ope
ratio
n ha
ve a
writ
ten
reco
rd o
f all
retu
rns a
nd, w
here
ap
plic
able
, its
inve
stig
atio
n, in
clud
ing
the
follo
win
g?
Id
entit
y of
pro
duct
;
Bat
ch, l
ot, o
r oth
er c
ontro
l num
ber o
f the
pro
duct
Dat
e th
e re
turn
ed p
rodu
ct w
as re
ceiv
ed;
N
ame
and
addr
ess f
rom
whi
ch it
was
retu
rned
and
the
mea
ns b
y w
hich
it w
as re
turn
ed;
R
easo
n fo
r the
retu
rn;
R
esul
ts o
f any
test
s or e
xam
inat
ion
cond
ucte
d on
the
retu
rned
pr
oduc
t or o
n re
late
d ba
tche
s, if
any;
Find
ings
of t
he in
vest
igat
ion
and
follo
w-u
p ac
tion
take
n w
hen
an
inve
stig
atio
n is
per
form
ed;
A
ny re
proc
essi
ng p
erfo
rmed
on
the
retu
rned
pro
duct
;
The
ultim
ate
disp
ositi
on o
f the
retu
rned
pro
duct
and
the
date
of
disp
ositi
on; a
nd
N
ames
of t
he q
ualit
y-co
ntro
l per
sonn
el w
ho d
o th
e fo
llow
ing:
◦
Rev
iew
the
reas
on fo
r the
pro
duct
retu
rn;
◦ R
evie
w a
nd a
ppro
ve a
ny re
proc
essi
ng, a
s app
licab
le, a
nd
◦ R
evie
w a
nd a
ppro
ve th
e fin
ding
s and
follo
w-u
p ac
tion
of
any
inve
stig
atio
n pe
rform
ed.
☐
☐
☐
SAMPLE
I9.3
(a) •
Rec
all p
roce
dure
s - D
oes t
he m
anuf
actu
ring,
pac
kagi
ng, l
abel
ing,
an
d ho
ldin
g op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng e
stabl
ishi
ng a
pr
oced
ure
for r
ecal
ling
a pr
oduc
t tha
t has
bee
n sh
own
to p
rese
nt a
reas
onab
le
or re
mot
e pr
obab
ility
that
the
use
of th
e pr
oduc
t will
cau
se se
rious
adv
erse
he
alth
con
sequ
ence
s or c
ould
cau
se te
mpo
rary
or m
edic
ally
reve
rsib
le a
dver
se
heal
th c
onse
quen
ces?
Doe
s thi
s pro
cedu
re in
clud
e th
e fo
llow
ing,
as r
equi
red?
Fact
ors w
hich
nec
essi
tate
a re
call;
Pers
onne
l res
pons
ible
for a
reca
ll; a
nd
N
otifi
catio
n pr
otoc
ols.
☐
☐
☐
I9.3
(b) •
Rec
all p
roce
dure
s - D
oes t
he m
anuf
actu
ring,
pac
kagi
ng, l
abel
ing,
an
d ho
ldin
g op
erat
ion
have
SO
Ps, p
roto
cols
, and
reco
rd k
eepi
ng e
stabl
ishi
ng a
pr
oced
ure
for c
omm
unic
atin
g a
reca
ll of
pro
duct
dis
tribu
ted
by th
e op
erat
ion?
D
oes t
his p
roce
dure
incl
ude
the
follo
win
g, a
s req
uire
d?
A
mec
hani
sm to
con
tact
all
cust
omer
s tha
t hav
e, o
r cou
ld h
ave,
ob
tain
ed th
e pr
oduc
t fro
m th
e op
erat
ion;
A m
echa
nism
to c
onta
ct th
e ve
ndor
that
supp
lied
the
reca
lled
prod
uct t
o th
e op
erat
ion,
if a
pplic
able
;
Inst
ruct
ions
for t
he re
turn
or d
estru
ctio
n of
any
reca
lled
prod
uct b
y cu
stom
ers;
Inst
ruct
ions
for c
ontra
ctin
g th
e re
leva
nt m
anuf
actu
ring,
pac
kagi
ng,
labe
ling,
and
/or h
oldi
ng o
pera
tions
; and
Com
mun
icat
ion
and
outre
ach
via
med
ia, a
s nec
essa
ry a
nd
appr
opria
te.
☐
☐
☐
*Not
requ
ired
by A
HPA
doc
umen
t, no
t nec
essa
rily
an a
udit
poin
t. SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
A1.
1 • S
ubje
ct o
pera
tions
– Is
this
ope
ratio
n su
bjec
t to
stat
e an
d/or
loca
l ov
ersi
ght?
*
☐
☐
☐
A1.
2 • O
ther
stat
utor
y pr
ovis
ions
and
reg
ulat
ions
– Is
the
labo
rato
ry
oper
atio
n pr
esen
tly c
ompl
iant
with
all
othe
r app
licab
le st
atut
ory
prov
isio
ns
and
regu
latio
ns re
late
d to
can
nabi
s lab
orat
ory
oper
atio
ns in
the
juris
dict
ion
in
whi
ch th
is p
art a
pplie
s, an
d re
late
d to
all
othe
r bus
ines
s act
iviti
es u
nder
take
n in
con
duct
ing
a la
bora
tory
ope
ratio
n?
☐
☐
☐
B2.
1(b)
(1) •
Sco
pe o
f Lab
orat
ory
func
tions
– D
oes t
he o
pera
tion
have
st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts (e
.g.,
SOPs
, wor
k in
stru
ctio
ns,
etc.
) for
ana
lytic
al te
stin
g of
can
nabi
s?*
☐
☐
☐
B2.
1(b)
(2)(
i-iv)
• Sc
ope
of L
abor
ator
y fu
nctio
ns –
Doe
s the
ope
ratio
n ha
ve
stan
dard
ized
pro
toco
ls, p
roce
dure
s, an
d re
ports
(i.e
., SO
Ps, w
ork
inst
ruct
ions
, et
c.) f
or a
naly
tical
test
ing
of c
anna
bis f
or p
urity
(mic
robi
olog
ical
org
anis
ms,
pest
icid
es, h
eavy
met
als,
solv
ents
, for
eign
mat
ter)
?*
☐
☐
☐
B2.
1(b)
(3)(
i-ii)
• Sco
pe o
f Lab
orat
ory
func
tions
– D
oes t
he o
pera
tion
have
st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts (i
.e.,
SOPs
, wor
k in
stru
ctio
ns,
etc.
) for
ana
lytic
al te
stin
g of
can
nabi
s for
pot
ency
(can
nabi
noid
con
tent
, te
rpen
oid
cont
ent)?
*
☐
☐
☐
SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
B2.
1(b)
(4) •
Sco
pe o
f Lab
orat
ory
func
tions
– D
oes t
he o
pera
tion
have
st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts (i
.e.,
SOPs
, wor
k in
stru
ctio
ns,
etc.
) for
ana
lytic
al te
stin
g of
can
nabi
s for
oth
er q
ualit
y fa
ctor
s (%
wat
er
cont
ent,
oil c
onte
nt, a
sh)?
*
☐
☐
☐
B2.
1(c)
(1) •
Can
nabi
s-de
rive
d pr
oduc
t ana
lysi
s – D
oes t
he la
bora
tory
hav
e st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts fo
r ana
lytic
al te
stin
g of
ca
nnab
is-d
eriv
ed p
rodu
cts?
*
☐
☐
☐
B2.
1(c)
(2) •
Can
nabi
s-de
rive
d pr
oduc
t ana
lysi
s – D
oes t
he la
bora
tory
hav
e st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts fo
r ana
lytic
al te
stin
g of
ca
nnab
is-d
eriv
ed p
rodu
cts f
or d
eter
min
atio
n of
any
fact
or o
f a p
rodu
ct’s
co
mpo
sitio
n or
nut
ritio
nal c
onte
nt?*
☐
☐
☐
B2.
1(d)
(1) •
SO
Ps fo
r ot
her
test
s and
exa
min
atio
n –
Doe
s the
labo
rato
ry
have
stan
dard
ized
pro
toco
ls, p
roce
dure
s, an
d re
ports
for g
ross
org
anol
eptic
an
alys
is?*
☐
☐
☐
B2.
1(d)
(2) •
SO
Ps fo
r te
sts a
nd e
xam
inat
ion
– D
oes t
he la
bora
tory
hav
e st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts fo
r mac
rosc
opic
?*
☐
☐
☐
B2.
1(d)
(3) •
SO
Ps fo
r te
sts a
nd e
xam
inat
ion
– D
oes t
he la
bora
tory
hav
e st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts fo
r mic
rosc
opic
?*
☐
☐
☐
B2.
1(d)
(4) •
SO
Ps fo
r te
sts a
nd e
xam
inat
ion
– D
oes t
he la
bora
tory
hav
e st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts fo
r che
mic
al a
naly
sis?
* ☐
☐
☐
B2.
1(d)
(5) •
SO
Ps fo
r te
sts a
nd e
xam
inat
ion
– D
oes t
he la
bora
tory
hav
e st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts fo
r gen
etic
ana
lysi
s?*
☐
☐
☐
B2.
1(d)
(6) •
SO
Ps fo
r te
sts a
nd e
xam
inat
ion
– D
oes t
he la
bora
tory
hav
e st
anda
rdiz
ed p
roto
cols
, pro
cedu
res,
and
repo
rts fo
r oth
er sc
ient
ifica
lly v
alid
m
etho
ds?*
☐
☐
☐
B3.
1(a)
(1-2
) • P
erso
nnel
trai
ning
– D
oes e
ach
pers
on e
ngag
ed in
a la
bora
tory
op
erat
ion
have
edu
catio
n, tr
aini
ng, e
xper
ienc
e, a
nd su
perv
isio
n, o
r any
co
mbi
natio
n th
ereo
f, to
ena
ble
that
per
son
to p
erfo
rm a
ll as
sign
ed fu
nctio
ns?
☐
☐
☐
B3.
1(a)
(1-2
) • P
erso
nnel
trai
ning
– Is
the
leve
l of e
duca
tion
and
train
ing
docu
men
ted
or k
now
n fo
r dire
ctor
s, m
anag
ers,
and
inst
rum
ent o
pera
tors
?*
☐
☐
☐
B3.
1(b)
• Pe
rson
nel t
rain
ing
– D
oes t
he la
bora
tory
pro
vide
all
empl
oyee
s w
ith tr
aini
ngs,
and
docu
men
t atte
ndan
ce a
t tra
inin
gs fo
r eac
h em
ploy
ee?
☐
☐
☐
B3.
1(b)
(1) •
Per
sonn
el tr
aini
ng –
Doe
s the
labo
rato
ry p
rovi
de a
ll em
ploy
ees
with
Inst
ruct
ions
rega
rdin
g re
gula
tory
insp
ectio
n pr
epar
edne
ss?
☐
☐
☐
SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
B3.
1(b)
(1) •
Per
sonn
el tr
aini
ng –
Doe
s the
labo
rato
ry p
rovi
de a
ll em
ploy
ees
with
inst
ruct
ions
rega
rdin
g la
w-e
nfor
cem
ent i
nter
actio
ns?
☐
☐
☐
B3.
1(b)
(2) •
Per
sonn
el tr
aini
ng –
Doe
s the
labo
rato
ry p
rovi
de a
ll em
ploy
ees
with
inst
ruct
ion
on U
.S. f
eder
al la
ws,
regu
latio
ns, a
nd p
olic
ies r
elat
ing
to
indi
vidu
als e
mpl
oyed
in th
ese
oper
atio
ns, a
nd th
e im
plic
atio
ns o
f the
se fo
r su
ch e
mpl
oyee
s?
☐
☐
☐
B3.
1(b)
• Pe
rson
nel t
rain
ing
– D
oes t
he la
bora
tory
pro
vide
all
empl
oyee
s w
ith sa
fety
sem
inar
s and
/or a
nnua
l ref
resh
er tr
aini
ngs f
or e
mpl
oyee
con
duct
w
ithin
lab
wor
kspa
ce (
e.g.
, che
mic
al w
aste
han
dlin
g)?*
☐
☐
☐
D4.
1(a)
(1)(
i) • P
hysi
cal f
acili
ties –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
it
oper
ates
in a
dher
ence
with
any
regu
latio
n in
the
juris
dict
ion
it op
erat
es fo
r lo
catio
ns a
nd z
onin
g fo
r all
type
of o
pera
tions
at t
he fa
cilit
y?
☐
☐
☐
D4.
1(a)
(1)(
ii) •
Phys
ical
faci
litie
s – D
oes t
he o
pera
tion
have
evi
denc
e th
at it
op
erat
es in
adh
eren
ce w
ith a
ny re
gula
tion
in th
e ju
risdi
ctio
n it
oper
ates
for
busi
ness
hou
rs?
☐
☐
☐
D4.
1(a)
(1)(
iii) •
Phy
sica
l fac
ilitie
s – D
oes t
he o
pera
tion
have
evi
denc
e th
at it
op
erat
es in
adh
eren
ce w
ith a
ny re
gula
tion
in th
e ju
risdi
ctio
n it
oper
ates
for
park
ing?
☐
☐
☐
D4.
1(a)
(1)(
iv) •
Phy
sica
l fac
ilitie
s – D
oes t
he o
pera
tion
have
evi
denc
e th
at it
op
erat
es in
adh
eren
ce w
ith a
ny re
gula
tion
in th
e ju
risdi
ctio
n it
oper
ates
for
driv
e-th
roug
h se
rvic
es?
☐
☐
☐
D4.
1(a)
(1)(
v) •
Phys
ical
faci
litie
s – D
oes t
he o
pera
tion
have
evi
denc
e th
at it
op
erat
es in
adh
eren
ce w
ith a
ny re
gula
tion
in th
e ju
risdi
ctio
n it
oper
ates
for
sign
age?
☐
☐
☐
D4.
1(a)
(2) •
Phy
sica
l fac
ilitie
s – D
oes t
he la
bora
tory
hav
e ev
iden
ce o
f bei
ng
mai
ntai
ned
in a
cle
an a
nd o
rder
ly fa
shio
n?
☐
☐
☐
D4.
1(a)
(3) •
Phy
sica
l fac
ilitie
s – Is
the
labo
rato
ry e
quip
ped
with
such
ute
nsils
as
are
nec
essa
ry to
con
duct
all
oper
atio
ns th
at o
ccur
at t
he fa
cilit
y?
☐
☐
☐
D4.
1(a)
(4) •
Phy
sica
l fac
ilitie
s – D
oes t
he la
bora
tory
pro
vide
ade
quat
e sp
ace
for o
pera
tions
, sam
ple
stor
age,
and
doc
umen
t sto
rage
? ☐
☐
☐
B4.
2(a)
• Se
curi
ty –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
that
it h
as e
stab
lishe
d an
d ad
here
s to
such
secu
rity
proc
edur
es a
s pro
vide
d by
regu
latio
n in
the
ju
risdi
ctio
n in
whi
ch th
is p
art a
pplie
s?
☐
☐
☐
SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
B4.
2(b)
(1) •
Sec
urity
– D
oes t
he o
pera
tion
prov
ide
addi
tiona
l sec
urity
as
need
ed to
pro
tect
em
ploy
ees d
urin
g w
orki
ng h
ours
and
in a
man
ner
appr
opria
te fo
r the
com
mun
ity w
here
it o
pera
tes?
☐
☐
☐
B4.
2(b)
(2) •
Sec
urity
– D
oes t
he fa
cilit
y pr
ovid
e tra
inin
g to
mak
e al
l em
ploy
ees a
war
e of
the
oper
atio
n’s s
ecur
ity p
roce
dure
s, an
d ea
ch in
divi
dual
em
ploy
ee’s
secu
rity
role
s and
resp
onsib
ilitie
s?
☐
☐
☐
B4.
2(c)
(1) •
Sec
urity
– D
oes t
he o
pera
tion
have
one
or m
ore
cont
rolle
d ac
cess
ar
eas f
or th
e st
orag
e of
can
nabi
s and
can
nabi
s-de
rived
test
sam
ples
? ☐
☐
☐
B4.
2(c)
(2) •
Sec
urity
– D
oes t
he o
pera
tion
have
one
or m
ore
cont
rolle
d ac
cess
ar
eas f
or th
e st
orag
e of
can
nabi
s was
te?
☐
☐
☐
B4.
2(c)
(3) •
Sec
urity
– D
oes t
he o
pera
tion
have
one
or m
ore
cont
rolle
d ac
cess
ar
eas f
or th
e st
orag
e of
refe
renc
e st
anda
rds f
or a
naly
sis o
f can
nabi
noid
s?
☐
☐
☐
B4.
2(c)
(4) •
Sec
urity
– D
oes t
he o
pera
tion
have
one
or m
ore
cont
rolle
d ac
cess
ar
eas f
or th
e st
orag
e of
any
oth
er c
ontro
lled
subs
tanc
es?
☐
☐
☐
D4.
2(d)
• Se
curi
ty –
Doe
s the
ope
ratio
n lim
it ac
cess
to c
ontro
lled
area
s by
lock
s, el
ectro
nic
badg
e re
ader
s, bi
omet
ric id
entif
iers
or o
ther
mea
ns?
☐
☐
☐
D4.
2(e)
• Se
curi
ty –
Are
app
ropr
iate
step
s tak
en to
ens
ure
acce
ss p
rivile
ges t
o th
e la
bora
tory
faci
lity
and
to c
ontro
lled
acce
ss a
reas
, as a
pplic
able
, are
re
voke
d fo
r per
sonn
el w
ho a
re n
o lo
nger
em
ploy
ed b
y th
e op
erat
ion?
☐
☐
☐
D4.
2(f)
• Se
curi
ty D
ocum
enta
tion
– A
re th
e pr
oced
ures
for s
ecur
ity
docu
men
ted
in a
writ
ten
form
at a
cces
sibl
e to
em
ploy
ees?
☐
☐
☐
E5.
1(a)
• Sa
mpl
e re
ceip
t – D
oes t
he o
pera
tion
docu
men
t and
trac
k sa
mpl
es
take
n fro
m a
ny c
ompl
iant
bus
ines
s or c
olle
cted
on
beha
lf of
thos
e en
titie
s?*
☐
☐
☐
E5.
1(b)
(1) •
Sam
ple
rece
ipt –
Doe
s the
ope
ratio
n ha
ve e
stab
lishe
d an
d
impl
emen
ted
polic
ies f
or c
olle
ctin
g te
st sa
mpl
es in
a m
anne
r tha
t ens
ures
that
th
e te
st sa
mpl
e ac
cura
tely
repr
esen
ts th
e m
ater
ial b
eing
sam
pled
?
☐
☐
☐
E5.
1(b)
(1) •
Sam
ple
rece
ipt –
Doe
s the
ope
ratio
n ha
ve e
stab
lishe
d an
d
impl
emen
ted
polic
ies f
or o
ther
par
amet
ers a
ffect
ing
sam
ple
prep
arat
ion,
do
cum
enta
tion,
and
tran
spor
t?
☐
☐
☐
E5.
1(b)
(2)(
i) • S
ampl
e re
ceip
t – D
oes t
he o
pera
tion’
s pol
icy
cont
ain
the
acce
pted
test
sam
ple
type
s?
☐
☐
☐
SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
E5.
1(b)
(2)(
ii) •
Sam
ple
rece
ipt –
Doe
s the
ope
ratio
n’s p
olic
y co
ntai
n th
e ac
cept
ed m
inim
um te
st sa
mpl
e si
ze?
☐
☐
☐
E5.
1(b)
(2)(
iii) •
Sam
ple
rece
ipt –
Doe
s the
ope
ratio
n’s p
olic
y co
ntai
n th
e in
form
atio
n on
the
reco
mm
ende
d te
st sa
mpl
e co
ntai
ner?
☐
☐
☐
E5.
1(b)
(2)(
iv) •
Sam
ple
rece
ipt –
Doe
s the
ope
ratio
n’s p
olic
y co
ntai
n in
form
atio
n on
test
sam
ple
labe
ling?
☐
☐
☐
E5.
1(b)
(2)(
v) •
Sam
ple
rece
ipt –
Doe
s the
ope
ratio
n’s p
olic
y co
ntai
n in
form
atio
n on
app
ropr
iate
tran
spor
t and
stor
age
cond
ition
s, su
ch a
s re
frige
ratio
n if
requ
ired?
☐
☐
☐
E5.
1(b)
(2)(
vi) •
Sam
ple
rece
ipt –
Doe
s the
ope
ratio
n’s p
olic
y co
ntai
n in
form
atio
n on
oth
er re
quire
men
ts, s
uch
as th
e us
e of
pre
serv
ativ
es, i
nert
gas,
or o
ther
mea
sure
s to
prot
ect s
ampl
e in
tegr
ity?
☐
☐
☐
E5.
1(b)
(2)(
vii)
• Sam
ple
rece
ipt –
Doe
s the
ope
ratio
n’s p
olic
y co
ntai
n th
e ac
cept
ed u
se o
f sam
ple
chai
n of
cus
tody
form
s?
☐
☐
☐
E5.
1(c)
(1) •
Sam
ple
rece
ipt –
Doe
s the
labo
rato
ry h
ave
docu
men
tatio
n or
a
reco
rd o
f eac
h te
st sa
mpl
e?
☐
☐
☐
E5.
1(c)
(1)(
i) • S
ampl
e re
ceip
t – D
oes t
he re
cord
incl
ude
the
nam
e an
d co
ntac
t of
com
plia
nt b
usin
ess o
r ind
ivid
ual t
hat w
as th
e so
urce
of t
he m
ater
ial?
☐
☐
☐
E5.
1(c)
(1)(
ii) •
Sam
ple
rece
ipt –
Doe
s the
reco
rd in
clud
e an
app
ropr
iate
ly
com
plet
e an
d sp
ecifi
c de
scrip
tion
of th
e sa
mpl
e?
☐
☐
☐
E5.
1(c)
(1)(
iii) •
Sam
ple
rece
ipt –
Doe
s the
reco
rd in
clud
e th
e da
te o
f rec
eipt
of
the
sam
ple?
☐
☐
☐
E5.
1(c)
(1)(
iv) •
Sam
ple
rece
ipt –
Doe
s the
reco
rd in
clud
e a
stat
emen
t of t
he
quan
tity
(wei
ght,
volu
me,
num
ber,
or o
ther
am
ount
) of t
he sa
mpl
e?
☐
☐
☐
E5.
1(c)
(1)(
v) •
Sam
ple
rece
ipt –
Doe
s the
reco
rd in
clud
e a
uniq
ue sa
mpl
e id
entif
ier f
or th
e sa
mpl
e?
☐
☐
☐
E5.
1(c)
(2) •
Sam
ple
rece
ipt –
Doe
s the
ope
ratio
n in
form
bus
ines
ses a
nd
com
plia
nt in
divi
dual
s tha
t sub
mit
test
sam
ples
of t
he p
olic
ies e
stab
lishe
d in
se
ctio
n E5
.1(b
)?
☐
☐
☐
SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
E5.
2(a)
• Sa
mpl
e H
andl
ing
– D
oes t
he o
pera
tion
have
pro
cedu
res
docu
men
ting
the
track
ing
of th
e sa
mpl
es th
roug
h th
e en
tire
anal
ytic
al p
roce
ss
(by
wei
ght,
volu
me,
num
ber,
or o
ther
app
ropr
iate
mea
sure
) to
prev
ent
dive
rsio
n?
☐
☐
☐
E5.
2(b)
• Sa
mpl
e H
andl
ing
– D
oes t
he o
pera
tion
store
eac
h sa
mpl
e un
der t
he
appr
opria
te c
ondi
tions
to p
rote
ct th
e ph
ysic
al a
nd c
hem
ical
inte
grity
of t
he
sam
ple?
☐
☐
☐
E5.
2(c)
• Sa
mpl
e H
andl
ing
– D
oes t
he o
pera
tion
appr
opria
tely
segr
egat
e,
cont
rol,
or h
old
sam
ples
con
sist
ing
of c
anna
bis o
r can
nabi
s-de
rived
pro
duct
s in
con
trolle
d ar
eas p
endi
ng d
estru
ctio
n or
dis
posa
l?
☐
☐
☐
E5.
2(d)
(1-3
) • S
ampl
e H
andl
ing
– D
oes t
he o
pera
tion
have
a d
ocum
ente
d pr
oced
ure
for c
anna
bis o
r can
nabi
s-de
rived
pro
duct
test
sam
ples
that
are
not
de
stro
yed
durin
g th
e an
alys
is, s
uch
as th
e fo
llow
ing?
Ret
urni
ng th
e sa
mpl
e to
the
indi
vidu
al o
r com
plai
nt b
usin
ess;
Stor
ing
and
reta
inin
g th
e sa
mpl
e in
con
form
ity w
ith o
pera
tion’
s sa
mpl
e re
tent
ion
polic
y; o
r
Des
troyi
ng in
a m
anne
r whi
ch p
reve
nts u
naut
horiz
ed u
se a
nd is
do
cum
ente
d ac
cord
ing
to S
ectio
n 5.
2 (d
)(3).
☐
☐
☐
E5.
2(e)
(1-3
) • S
ampl
e H
andl
ing
–Doe
s the
ope
ratio
n di
spos
e of
any
por
tion
of h
emp
or h
emp-
deriv
ed p
rodu
ct th
at is
not
des
troye
d du
ring
anal
ysis
, by
a m
etho
d su
ch a
s the
follo
win
g?
R
etur
ning
the
sam
ple
to th
e sa
me
com
plai
nt in
divi
dual
or b
usin
ess
that
pro
vide
s a sa
mpl
e, o
r
Stor
age
and
rete
ntio
n of
the
sam
ple
in c
onfo
rmity
with
the
labo
rato
ry o
pera
tions
sam
ple
rete
ntio
n po
licy,
if a
ny; o
r
Dis
pose
d of
in a
ny a
ppro
pria
te m
anne
r?
☐
☐
☐
F6.1
(a) •
Equ
ipm
ent –
Doe
s the
ope
ratio
n d
ocum
ent i
nspe
ctio
n, c
lean
ing,
m
aint
enan
ce, a
nd c
alib
ratio
n of
equ
ipm
ent,
on a
n ap
prop
riate
sche
dule
, as
appl
icab
le?
☐
☐
☐
F6.1
(b) •
Equ
ipm
ent –
Doe
s the
ope
ratio
n do
cum
ent p
roce
dure
s use
d in
the
rout
ine
insp
ectio
n, c
lean
ing,
mai
nten
ance
, tes
ting,
and
cal
ibra
tion
of
equi
pmen
t?
☐
☐
☐
SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
F6.1
(b) •
Equ
ipm
ent –
Doe
s the
ope
ratio
n sp
ecify
and
doc
umen
t whe
n re
med
ial a
ctio
n m
ust b
e ta
ken
in th
e ev
ent o
f fai
lure
or m
alfu
nctio
n of
eq
uipm
ent?
The
pro
cedu
res m
ust d
esig
nate
the
pers
onne
l res
pons
ible
for t
he
perfo
rman
ce o
f eac
h op
erat
ion.
☐
☐
☐
F6.1
(c) •
Equ
ipm
ent –
Are
reco
rds m
aint
aine
d of
all
insp
ectio
ns,
mai
nten
ance
, tes
ting,
and
cal
ibra
ting?
☐
☐
☐
F6.1
(c) •
Equ
ipm
ent –
Do
the
reco
rds i
nclu
de th
e da
te o
f the
ope
ratio
n pe
rform
ed, t
he p
roce
dure
use
d, a
nd a
ny d
evia
tions
of a
writ
ten
proc
edur
e?
☐
☐
☐
F6.1
(c) •
Equ
ipm
ent –
Do
the
reco
rds i
nclu
de n
on-r
outin
e re
pairs
on
equi
pmen
t as a
resu
lt of
failu
re a
nd m
alfu
nctio
n?
☐
☐
☐
F6.1
(c) •
Equ
ipm
ent –
Do
the
reco
rds i
nclu
de th
e do
cum
enta
tion
of re
pairs
w
ith th
e na
ture
of r
epai
r, ho
w a
nd w
hen
the
need
for r
epai
r was
disc
over
ed,
and
any
rem
edia
l act
ion
take
n in
resp
onse
to re
pair?
☐
☐
☐
F6.1
(d) •
Equ
ipm
ent –
Doe
s the
ope
ratio
n en
sure
that
com
pute
r sys
tem
s use
d fo
r lab
orat
ory
func
tions
such
as e
lect
roni
c re
cord
s, el
ectro
nic
sign
atur
es, a
nd
hand
writ
ten
sign
atur
es e
xecu
ted
to e
lect
roni
c re
cord
s are
trus
twor
thy,
relia
ble,
an
d ge
nera
lly e
quiv
alen
t to
hand
writ
ten
sign
atur
es e
xecu
ted
on p
aper
?
☐
☐
☐
F6.2
(a)(
1) •
Rea
gent
s – D
oes t
he o
pera
tion
labe
l ana
lytic
reag
ents
, sol
utio
ns,
and
refe
renc
e st
anda
rds w
ith a
ppro
pria
te in
dica
tions
of i
dent
ity, d
ate
rece
ived
or
pre
pare
d, e
xpira
tion
or re
qual
ifica
tion
date
, and
, whe
re a
pplic
able
, co
ncen
tratio
n or
pur
ity, s
tora
ge re
quire
men
ts, a
nd d
ate
open
ed?
☐
☐
☐
F6.2
(a)(
2) •
Rea
gent
s – A
re a
naly
tical
reag
ents
, sol
utio
ns, a
nd re
fere
nce
stan
dard
s sto
red
unde
r app
ropr
iate
con
ditio
ns to
min
imiz
e de
grad
atio
n or
de
terio
ratio
n of
the
mat
eria
l?
☐
☐
☐
F6.2
(a)(
3) •
Rea
gent
s – A
re a
naly
tical
reag
ents
, sol
utio
ns, r
efer
ence
stan
dard
s w
ithin
thei
r exp
iratio
n re
qual
ifica
tion
date
s at t
he ti
me
of u
se?
☐
☐
☐
F6.2
(b) •
Rea
gent
s – D
oes t
he o
pera
tion
prop
erly
dis
card
det
erio
rate
d or
ou
tdat
ed re
agen
ts a
nd so
lutio
ns?
☐
☐
☐
F6.2
(c) •
Rea
gent
s – D
oes a
labo
rato
ry o
pera
tion
acqu
ire c
omm
erci
al
refe
renc
e st
anda
rds f
or th
e ca
nnab
inoi
ds b
eing
ana
lyze
d?
☐
☐
☐
F6.2
(d) •
Rea
gent
s – If
the
oper
atio
n in
tern
ally
pro
duce
s sta
ndar
ds, a
re
stan
dard
ana
lytic
al te
chni
ques
use
d to
doc
umen
t the
pur
ity a
nd c
once
ntra
tion
of th
e in
tern
ally
pro
duce
d st
anda
rd?
☐
☐
☐
SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
F6.2
(e) •
Rea
gent
s – If
the
oper
atio
n in
tern
ally
pro
duce
s sta
ndar
ds, d
oes t
he
oper
atio
n cr
eate
a c
ertif
icat
e of
ana
lysi
s (C
OA
) for
eac
h lo
t of r
efer
ence
st
anda
rds?
*
☐
☐
☐
F6.2
(e) •
Rea
gent
s – If
the
oper
atio
n in
tern
ally
pro
duce
s sta
ndar
ds, i
s eac
h C
OA
kep
t on
file
and
lot n
umbe
r of t
he re
fere
nce
stan
dard
use
d an
d re
cord
ed
in th
e do
cum
enta
tion
for e
ach
anal
ysis
, whe
re a
pplic
able
?
☐
☐
☐
G7.
1(a)
(1) •
Ana
lytic
al P
roce
dure
s – D
oes t
he o
pera
tion
utili
ze a
naly
tical
m
etho
ds th
at a
re fi
t for
pur
pose
in th
eir t
estin
g of
eac
h ca
nnab
is p
rodu
ct?
☐
☐
☐
G7.
1(a)
(2) •
Ana
lytic
al P
roce
dure
s – D
oes t
he o
pera
tion
have
doc
umen
tatio
n de
mon
stra
ting
the
prof
icie
ncy
of e
ach
anal
yst?
☐
☐
☐
G7.
1(a)
(3) •
Ana
lytic
al P
roce
dure
s – D
oes t
he o
pera
tion
have
writ
ten
proc
edur
es fo
r the
follo
win
g, w
here
app
licab
le:
Sa
mpl
e pr
epar
atio
n
R
eage
nt so
lutio
n, a
nd re
fere
nce
stan
dard
pre
para
tion
Inst
rum
ent s
et u
p
St
anda
rdiz
atio
n of
vol
umet
ric re
agen
t sol
utio
ns
D
ata
acqu
isiti
on
C
alcu
latio
n of
resu
lts
☐
☐
☐
G7.
1(a)
(4) •
Ana
lytic
al P
roce
dure
s – H
as th
e op
erat
ion,
as a
pplic
able
to e
ach
anal
ytic
al m
etho
d us
ed, s
peci
fied
the
requ
irem
ents
for a
ccur
acy,
pre
cisi
on,
linea
rity,
spec
ifici
ty, l
imit
of d
etec
tion,
lim
it of
qua
ntita
tion,
and
oth
er d
ata
qual
ity p
aram
eter
s?
☐
☐
☐
G7.
1(a)
(5) •
Ana
lytic
al P
roce
dure
s – D
oes t
he o
pera
tion
docu
men
t any
de
viat
ions
from
app
rove
d pr
otoc
ols o
r sta
ndar
d op
erat
ing
proc
edur
es?
☐
☐
☐
G7.
1(b)
• A
naly
tical
Pro
cedu
res
– D
oes t
he la
bora
tory
use
onl
y pr
imar
y or
se
cond
ary
stan
dard
s for
qua
ntita
tive
anal
yses
? ☐
☐
☐
G7.
2(a)
• R
ecor
ding
of a
naly
tical
dat
a (n
on-a
utom
ated
syst
ems)
– A
re d
ata
from
test
sam
ples
reco
rded
dire
ctly
, pro
mpt
ly a
nd le
gibl
y?
☐
☐
☐
G7.
2(a)
• R
ecor
ding
of a
naly
tical
dat
a (n
on-a
utom
ated
syst
ems)
– I
s the
da
ta a
nnot
ated
with
the
date
of e
ntry
and
sign
ed o
r ini
tiale
d by
the
pers
on
reco
rdin
g th
e da
ta?
☐
☐
☐
SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
G7.
2(a)
• R
ecor
ding
of a
naly
tical
dat
a (n
on-a
utom
ated
syst
ems)
– D
o an
y ch
ange
s in
entri
es n
ot o
bscu
re o
rigin
al e
ntrie
s and
indi
cate
the
reas
on fo
r suc
h ch
ange
, with
dat
e an
d si
gnat
ure
or in
itial
at t
he ti
me
of c
hang
e?
☐
☐
☐
G7.
2(b)
• R
ecor
ding
of a
naly
tical
dat
a (a
utom
ated
syst
ems)
– Is
the
oper
ator
or t
echn
icia
n re
spon
sible
for i
nput
ting
data
into
aut
omat
ed d
ata
colle
ctio
n sy
stem
s ide
ntifi
ed w
ith th
e da
te o
f dat
a in
put?
☐
☐
☐
G7.
3(1)
• D
ata
revi
ew –
In th
e re
porti
ng o
f the
fina
l res
ult,
is th
ere
verif
icat
ion
that
cal
cula
tions
or o
ther
dat
a pr
oces
sing
step
s wer
e pe
rform
ed
corr
ectly
?
☐
☐
☐
G7.
3(2)
• D
ata
revi
ew –
In
the
repo
rting
of t
he fi
nal r
esul
t, do
es th
e da
ta
mee
t any
spec
ified
dat
a qu
ality
requ
irem
ents
, suc
h as
for a
ccur
acy,
pre
cisi
on,
and
linea
rity,
etc
.?
☐
☐
☐
G7.
3(3)
• D
ata
revi
ew –
In
the
repo
rting
of t
he fi
nal r
esul
t, w
ere
refe
renc
e st
anda
rds u
sed
of a
ppro
pria
te p
urity
and
with
in e
xpira
tion
or re
qual
ifica
tion
date
s?
☐
☐
☐
G7.
3(4)
• D
ata
revi
ew –
In
the
repo
rting
of t
he fi
nal r
esul
t, w
ere
volu
met
ric
solu
tions
pro
perly
stan
dard
ized
bef
ore
use?
☐
☐
☐
G7.
3(5)
• D
ata
revi
ew –
In
the
repo
rting
of t
he fi
nal r
esul
t, ha
s any
test
or
mea
surin
g eq
uipm
ent u
sed
been
pro
perly
test
ed, v
erifi
ed, a
nd/o
r cal
ibra
ted
and
is w
ithin
its v
erifi
catio
n or
cal
ibra
tion
perio
d?
☐
☐
☐
G7.
4(a)
• D
ata
stor
age
– D
oes t
he o
pera
tion
reta
in a
ll ra
w d
ata,
do
cum
enta
tion,
pro
toco
ls, a
nd fi
nal r
epor
ts a
ssoc
iate
d w
ith a
naly
sis o
f tes
t sa
mpl
es fo
r a p
erio
d of
2 y
ears
from
the
date
of c
ompl
etio
n of
the
anal
ysis
?s
☐
☐
☐
G7.
4(b)
(1) •
Dat
a st
orag
e –
Are
labo
rato
ry re
cord
s ind
icat
ed in
G7.
4(a)
, w
heth
er st
ored
on
the
prem
ises
or r
emot
ely,
mai
ntai
ned
in a
man
ner t
hat
allo
ws r
etrie
val a
s nee
ded?
☐
☐
☐
G7.
4(b)
(2) •
Dat
a st
orag
e –
Are
labo
rato
ry re
cord
s ind
icat
ed in
G7.
4(a)
, w
heth
er st
ored
on
the
prem
ises
or r
emot
ely,
mai
ntai
ned
in c
ondi
tions
of
stor
age
that
min
imiz
e de
terio
ratio
n th
roug
hout
the
rete
ntio
n pe
riod?
☐
☐
☐
G7.
4(b)
(3) •
Dat
a st
orag
e –
Are
labo
rato
ry re
cord
s ind
icat
ed in
G7.
4(a)
, w
heth
er st
ored
on
the
prem
ises
or r
emot
ely,
mai
ntai
ned
in a
man
ner t
hat
prev
ents
una
utho
rized
alte
ratio
n?
☐
☐
☐
SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
G7.
4(c)
• D
ata
stor
age
– D
oes t
he o
pera
tion
desi
gnat
e an
indi
vidu
al
resp
onsib
le fo
r rec
ords
mai
nten
ance
?
☐
☐
☐
G7.
4(d)
• D
ata
stor
age
– D
oes t
he o
pera
tion
ensu
re th
at o
nly
auth
oriz
ed
pers
onne
l may
ent
er o
r acc
ess t
he m
aint
aine
d re
cord
s?
☐
☐
☐
G7.
5(a)
• D
ata
repo
rtin
g -
Are
the
anal
ytic
al re
sults
of a
ny te
st sa
mpl
e th
e pr
oper
ty o
f the
com
plia
nt b
usin
ess o
r com
plia
nt in
divi
dual
whi
ch p
rovi
ded
the
sam
ple
(unl
ess c
ontra
cts o
r oth
er w
ritte
n ag
reem
ents
spec
ify o
ther
wis
e)?*
☐
☐
☐
G7.
5(b)
(1) •
Dat
a re
port
ing
- D
oes t
he o
pera
tion’
s lab
orat
ory
repo
rt gi
ven
to
a cl
ient
con
tain
the
date
of r
ecei
pt o
f the
test
sam
ple?
☐
☐
☐
G7.
5(b)
(2) •
Dat
a re
port
ing
- D
oes t
he o
pera
tion’
s lab
orat
ory
repo
rt gi
ven
to
a cl
ient
con
tain
a d
escr
iptio
n of
the
type
or f
orm
of t
he te
st sa
mpl
e (le
af,
flow
er, p
owde
r, oi
l, sp
ecifi
c ed
ible
pro
duct
, etc
.)?
☐
☐
☐
G7.
5(b)
(3) •
Dat
a re
port
ing
- D
oes t
he o
pera
tion’
s lab
orat
ory
repo
rt gi
ven
to
a cl
ient
con
tain
the
uniq
ue sa
mpl
e id
entif
ier a
s est
ablis
hed
in a
ccor
danc
e w
ith
subp
arag
raph
5.1
(b)(1
)(v)
?
☐
☐
☐
G7.
5(b)
(4) •
Dat
a re
port
ing
- D
oes t
he o
pera
tion’
s lab
orat
ory
repo
rt gi
ven
to
a cl
ient
con
tain
info
rmat
ion
on w
heth
er sa
mpl
ing
was
per
form
ed b
y th
e la
bora
tory
ope
ratio
n, b
y th
e co
mpl
iant
bus
ines
s or i
ndiv
idua
l whi
ch su
bmitt
ed
the
test
sam
ple,
or b
y a
third
-par
ty?
☐
☐
☐
G7.
5(b)
(5) •
Dat
a re
port
ing
- D
oes t
he o
pera
tion’
s lab
orat
ory
repo
rt gi
ven
to
a cl
ient
con
tain
the
date
on
whi
ch a
naly
sis o
ccur
red?
☐
☐
☐
G7.
5(b)
(6) •
Dat
a re
port
ing
- D
oes t
he o
pera
tion’
s lab
orat
ory
repo
rt gi
ven
to
a cl
ient
con
tain
the
anal
ytic
al m
etho
d us
ed, i
nclu
ding
at a
min
imum
id
entif
icat
ion
of th
e ty
pe o
f ana
lytic
al e
quip
men
t use
d (e
.g.,
GC
, HPL
C, U
V,
etc.
)?
☐
☐
☐
G7.
5(b)
(7) •
Dat
a re
port
ing
- D
oes t
he o
pera
tion’
s lab
orat
ory
repo
rt gi
ven
to
a cl
ient
con
tain
the
anal
ytic
al re
sults
, inc
ludi
ng u
nits
of m
easu
re w
here
ap
plic
able
?
☐
☐
☐
G7.
5(b)
(8) •
Dat
a re
port
ing
- D
oes t
he o
pera
tion’
s lab
orat
ory
repo
rt gi
ven
to
a cl
ient
con
tain
the
iden
tity
of th
e su
perv
isor
y or
man
agem
ent p
erso
nnel
who
re
view
ed a
nd v
erifi
ed th
e da
ta a
nd re
sults
and
ens
ured
that
dat
a qu
ality
, ca
libra
tion,
and
oth
er a
pplic
able
requ
irem
ents
wer
e m
et?
☐
☐
☐
SAMPLE
IT
EM
S N
EED
ED
FO
R C
OM
PLI
AN
CE
G7.
5(b)
(9) •
Dat
a re
port
ing
- D
oes t
he o
pera
tion’
s lab
orat
ory
repo
rt gi
ven
to
a cl
ient
con
tain
the
nam
e, a
ddre
ss, a
nd c
onta
ct in
form
atio
n of
the
labo
rato
ry
oper
atio
n?
☐
☐
☐
G7.
5(c)
(1) •
Dat
a re
port
ing
- If a
labo
rato
ry o
pera
tion
repo
rts c
anna
bino
id
valu
es o
ther
than
thos
e di
rect
ly m
easu
red
in th
e te
st sa
mpl
e, d
oes t
he re
port
cont
ain
all c
alcu
latio
ns o
r con
vers
ion
fact
ors u
sed
to d
eter
min
e th
e re
porte
d no
n-m
easu
red
resu
lts?
☐
☐
☐
G7.
5(c)
(2) •
Dat
a re
port
ing
- If a
labo
rato
ry o
pera
tion
repo
rts c
anna
bino
id
valu
es o
ther
than
thos
e di
rect
ly m
easu
red
in th
e te
st sa
mpl
e, d
oes t
he re
port
cont
ain
a w
ritte
n ex
plan
atio
n of
ass
umpt
ions
, if a
ny, a
ssoc
iate
d w
ith th
e re
porte
d no
n-m
easu
red
resu
lts, s
uch
as th
e ro
ute
of c
onsu
mpt
ion
of th
e pr
oduc
t rep
rese
nted
by
the
test
sam
ple?
☐
☐
☐
G7.
5(d)
• D
ata
repo
rtin
g –
Doe
s the
labo
rato
ry re
port
stat
e th
at re
porte
d an
alyt
ical
resu
lts a
pply
onl
y to
the
test
sam
ple
rece
ived
? ☐
☐
☐
*N
ot
req
uire
d b
y A
HP
A d
oc
um
en
t, n
ot
ne
ce
ssa
rily
an
au
dit p
oin
t. SAMPLE
A1.
1 • S
ubje
ct o
pera
tions
– Is
this
ope
ratio
n is
subj
ect t
o st
ate
and/
or lo
cal
over
sigh
t?
☐
☐
☐
A1.
2 • O
ther
stat
utor
y pr
ovis
ions
and
reg
ulat
ions
– Is
this
ope
ratio
n co
mpl
iant
(i.e
. has
a li
cens
e in
goo
d st
andi
ng, c
ertif
icat
e of
occ
upan
cy,
conf
iden
tialit
y re
quire
men
ts, l
abel
ing
and
test
ing
requ
irem
ents
, etc
.) w
ith a
ll ap
plic
able
regu
latio
ns in
the
juris
dict
ion
it op
erat
es?
☐
☐
☐
B2.
1(a)
• T
ypes
of d
istr
ibut
ion
oper
atio
ns –
Is th
is o
pera
tion
a st
oref
ront
, a
stor
efro
nt w
ith a
del
iver
y se
rvic
e, d
eliv
ery
serv
ice,
or d
irect
from
gar
den
oper
atio
n? O
r is t
his o
pera
tion
a gr
owin
g co
oper
ativ
e su
bjec
t to
regu
lato
ry
over
sigh
t?
☐
☐
☐
B2.
1(b)
(1) •
Can
nabi
s acq
uisi
tion
and
dist
ribu
tion
– D
oes t
he o
pera
tion
have
pol
icie
s and
pro
cedu
res t
o lim
it th
e di
strib
utio
n of
can
nabi
s to
cann
abis
th
at h
as b
een:
Cul
tivat
ed b
y th
e op
erat
ion
itsel
f;
Cul
tivat
ed b
y a
co-o
wne
d op
erat
ion;
or
O
btai
ned
from
a c
ultiv
atio
n op
erat
ion
or v
endo
r?
☐
☐
☐
SAMPLE
B2.
1(b)
(2) •
Can
nabi
s-de
rive
d pr
oduc
t dis
trib
utio
n –
Doe
s the
ope
ratio
n ha
ve p
olic
ies a
nd p
roce
dure
s to
limit
the
dist
ribut
ion
of c
anna
bis-
deriv
ed
prod
ucts
to c
anna
bis-
deriv
ed p
rodu
cts t
hat h
ave
been
:
Man
ufac
ture
d by
the
oper
atio
n its
elf;
M
anuf
actu
red
by a
co-
owne
d op
erat
ion;
or
O
btai
ned
from
a m
anuf
actu
ring
oper
atio
n or
ven
dor?
☐
☐
☐
B2.
2 • A
ncill
ary
oper
atio
ns –
If th
ere
are
oper
atio
ns o
ther
than
can
nabi
s di
strib
utio
n co
nduc
ted
at th
e lo
catio
n, is
ther
e su
ffici
ent e
vide
nce
that
thes
e an
cilla
ry o
pera
tions
are
con
duct
ed in
com
plia
nce
with
all
regu
latio
ns in
the
juris
dict
ion
it op
erat
es?
☐
☐
☐
B2.
3(a,
b, c
) • P
erso
nnel
trai
ning
– D
oes t
he o
pera
tion
have
a m
echa
nism
for
com
mun
icat
ing
with
all
empl
oyee
s and
hav
e ev
iden
ce th
at e
mpl
oyee
s hav
e re
ceiv
ed tr
aini
ng, i
nclu
ding
the
follo
win
g?
Sp
ecifi
c us
es o
f can
nabi
s or a
spec
ific
cann
abis
-der
ived
pro
duct
;
Clin
ical
app
licat
ion
of th
e sp
ecifi
c co
nstit
uent
s;
Th
e la
ws,
regu
latio
ns, a
nd p
olic
ies r
elev
ant t
o pr
ovid
ing
cann
abis
pr
oduc
ts in
its j
uris
dict
ion
as w
ell a
s U.S
. fed
eral
law
s and
re
gula
tions
; and
Inst
ruct
ion
for r
egul
ator
y in
spec
tion
prep
ared
ness
and
law
-en
forc
emen
t int
erac
tions
.
☐
☐
☐
B2.
3(d,
e) •
CPR
– If
the
oper
atio
n is
a st
oref
ront
ope
ratio
n, h
as it
ens
ured
th
at a
pro
perly
trai
ned
empl
oyee
is p
repa
red
to a
dmin
iste
r CPR
at a
ll tim
es
whe
n th
e op
erat
ion
is o
pen
for b
usin
ess?
NO
TE: t
here
may
be
valid
lega
l re
ason
s to
proh
ibit
com
plia
nce
with
this
regu
latio
n in
cer
tain
juris
dict
ions
.
☐
☐
☐
B2.
4(a)
(1) •
Phy
sica
l fac
ilitie
s – D
oes t
he o
pera
tion
have
suffi
cien
t evi
denc
e th
at it
ope
rate
s in
adhe
renc
e w
ith a
ll re
gula
tions
in th
e ju
risdi
ctio
n it
oper
ates
, in
clud
ing:
Loca
tions
and
zon
ing,
for a
ll ty
pe o
f ope
ratio
ns a
t the
faci
lity;
Bus
ines
s hou
rs;
Pa
rkin
g;
D
rive-
thro
ugh
serv
ices
; and
Sign
age?
☐
☐
☐
SAMPLE
B2.
4(a)
(2) •
Phy
sica
l fac
ilitie
s – D
oes t
he o
pera
tion
have
SO
Ps a
nd re
cord
ke
epin
g in
pla
ce su
ffici
ent t
o pr
ovid
e ev
iden
ce th
at it
is m
aint
aine
d in
a c
lean
an
d or
derly
fash
ion?
☐
☐
☐
B2.
4(a)
(3) •
Phy
sica
l fac
ilitie
s – Is
this
ope
ratio
n eq
uipp
ed w
ith u
tens
ils a
nd
equi
pmen
t as a
re n
eces
sary
to c
ondu
ct o
pera
tions
, inc
ludi
ng a
ncill
ary
oper
atio
ns a
s des
crib
ed in
sect
ion
2.2,
that
occ
ur a
t the
faci
lity?
☐
☐
☐
B2.
4(a)
(4) •
Pri
vacy
of t
rans
actio
ns –
Doe
s the
ope
ratio
n ha
ve e
vide
nce
it ha
s im
plem
ente
d a
priv
acy
of fi
nanc
ial t
rans
actio
ns p
olic
y?
☐
☐
☐
B2.
4(a)
(5) •
Pat
ient
lega
l inf
orm
atio
n –
Doe
s the
ope
ratio
n ha
ve in
form
atio
n av
aila
ble
to p
atie
nts a
nd c
areg
iver
s reg
ardi
ng lo
cal,
stat
e an
d fe
dera
l law
s on
cann
abis
pos
sess
ion?
☐
☐
☐
B2.
4(b)
• St
orag
e of
pro
duct
and
cas
h –
Doe
s the
ope
ratio
n do
the
follo
win
g?
A
dequ
atel
y re
frige
rate
pro
duct
s tha
t req
uire
refri
gera
tion;
Prov
ide
and
use
a se
cure
are
a fo
r sto
rage
of a
ll ca
nnab
is p
rodu
cts;
an
d
Prov
ide
and
use
a se
cure
are
a to
stor
e m
oney
and
hav
e pr
oced
ures
in
plac
e to
rem
ove
mon
ey fr
om th
e pr
emis
es fr
eque
ntly
?
☐
☐
☐
B2.
4(c)
(1) •
AD
A –
Doe
s the
ope
ratio
n ha
ve su
ffici
ent e
vide
nce
that
it is
in
com
plia
nce
with
app
licab
le A
mer
ican
s with
Dis
abili
ties A
ct p
rovi
sion
s or
equi
vale
nt re
gula
tions
in th
e ju
risdi
ctio
n it
oper
ates
?
☐
☐
☐
B2.
4(c)
(2) •
On-
site
con
sum
ptio
n –
Doe
s the
ope
ratio
n ha
ve a
pol
icy
in p
lace
re
gard
ing
on-s
ite c
onsu
mpt
ion?
If th
e op
erat
ion
allo
ws o
n-si
te c
onsu
mpt
ion,
is
it in
com
plia
nce
with
all
regu
latio
ns in
the
juris
dict
ion
whi
ch it
ope
rate
s?
Doe
s the
con
sum
ptio
n po
licy
addr
ess t
he fo
llow
ing?
The
type
or t
ypes
of c
onsu
mpt
ion
allo
wed
;
A ti
me
limit
to o
n-sit
e co
nsum
ptio
n if
advi
sabl
e;
A
ven
tilat
ion
plan
if n
eede
d;
A
pro
toco
l to
prev
ent a
nd a
ddre
ss o
ver-
med
icat
ion;
and
Any
add
ition
al is
sues
as n
eede
d.
☐
☐
☐
SAMPLE
B2.
5(a)
,(b)(
1)(i)
• Se
curi
ty p
ract
ices
– D
oes t
he o
pera
tion
have
sign
ifica
nt
evid
ence
that
it is
in c
ompl
ianc
e w
ith re
quire
d se
curit
y re
gula
tions
in th
e ju
risdi
ctio
n it
oper
ates
, inc
ludi
ng su
ffici
ent i
n-st
ore
secu
rity
pers
onne
l to
ensu
re st
aff a
nd p
atie
nt se
curit
y; in
-sto
re se
curit
y ca
mer
as; a
nd e
ither
secu
rity
pers
onne
l or
vid
eo m
onito
ring
of d
edic
ated
par
king
are
a?
☐
☐
☐
B2.
5(b)
(1)(
ii)(A
)&(B
) • S
ecur
ity p
ract
ices
– If
this
ope
ratio
n is
a d
eliv
ery
serv
ice,
doe
s the
ope
ratio
n ha
ve si
gnifi
cant
evi
denc
e th
at it
is in
com
plia
nce
with
requ
ired
secu
rity
regu
latio
ns in
the
juris
dict
ion
it op
erat
es, i
nclu
ding
su
ffici
ent s
ecur
ity p
erso
nnel
at t
he fa
cilit
y w
here
pro
duct
s are
acq
uire
d,
stor
ed, a
nd/o
r pro
cess
ed to
ens
ure
the
safe
ty o
f sta
ff an
d th
e se
curit
y of
all
prod
ucts
? D
oes i
t pro
vide
app
ropr
iate
trai
ning
for d
eliv
ery
staf
f to
ensu
re
awar
enes
s on
how
to m
aint
ain
pers
onal
and
pro
duct
safe
ty, i
nclu
ding
con
tact
in
form
atio
n fo
r pol
ice
and
othe
r em
erge
ncy
pers
onne
l?
☐
☐
☐
B2.
5(b)
(1)(
ii)(C
)&(D
) • S
ecur
ity p
ract
ices
– D
oes t
he d
eliv
er o
pera
tion
have
si
gnifi
cant
evi
denc
e th
at it
del
iver
s ON
LY to
priv
ate
addr
esse
s and
nev
er to
a
publ
ic lo
catio
n, a
nd th
at it
is in
com
plia
nce
with
all
loca
l reg
ulat
ions
rega
rdin
g pe
rmis
sibl
e de
liver
y ar
eas a
nd h
ours
of o
pera
tion?
☐
☐
☐
B2.
5(b)
(1)(
iii)(
A) •
Sec
urity
pra
ctic
es –
If th
is o
pera
tion
is a
dire
ct-fr
om-
gard
en o
r a g
row
ing
co-o
p, d
oes i
t hav
e si
gnifi
cant
evi
denc
e th
at it
has
the
nece
ssar
y se
curit
y pr
actic
es in
pla
ce a
t the
gro
win
g fa
cilit
y an
d at
any
as
soci
ated
loca
tions
whe
re c
anna
bis o
r can
nabi
s-de
rived
pro
duct
s or m
oney
ar
e ke
pt to
ens
ure
the
safe
ty o
f sta
ff an
d th
e se
curit
y of
can
nabi
s on
site
?
☐
☐
☐
B2.
5(b)
(2) •
Arm
ed se
curi
ty –
Doe
s the
ope
ratio
n re
frain
from
usi
ng a
rmed
se
curit
y pe
rson
nel o
r hav
e su
ffici
ent e
vide
nce
that
they
are
usi
ng a
rmed
se
curit
y in
stric
t acc
orda
nce
with
all
rele
vant
lega
l req
uire
men
ts in
the
juris
dict
ion
they
ope
rate
?
☐
☐
☐
B2.
5(b)
(3) •
Sec
urity
trai
ning
– D
oes t
he o
pera
tion
have
suffi
cien
t evi
denc
e th
at it
pro
vide
s sta
ff w
ith se
curit
y pr
oced
ures
and
ens
ures
staf
f is a
war
e of
th
eir i
ndiv
idua
l rol
es a
nd re
spon
sibili
ties?
☐
☐
☐
B2.
5(c)
• Se
curi
ty a
t anc
illar
y op
erat
ions
– If
the
oper
atio
n is
also
eng
aged
in
cul
tivat
ion,
pro
cess
ing,
or m
anuf
actu
ring
oper
atio
ns, d
oes i
t hav
e su
ffici
ent
evid
ence
that
it is
com
plia
nt w
ith se
curit
y re
quire
men
ts fo
r suc
h op
erat
ions
?
☐
☐
☐
SAMPLE
C3.
1(a)
• C
anna
bis p
rovi
sion
rec
ords
– D
oes t
he o
pera
tion
offe
r the
fo
llow
ing
item
s, as
allo
wed
by
regu
latio
ns in
the
juris
dict
ion
if op
erat
es:
smok
ed c
anna
bis,
vapo
rized
can
nabi
s, or
al c
anna
bis,
and/
or to
pica
l can
nabi
s?
☐
☐
☐
C3.
1(b)
(1),
(2),
(3) •
Can
nabi
s pro
visi
on r
ecor
ds –
Doe
s the
ope
ratio
n m
aint
ain
up-to
-dat
e re
cord
s on
all c
anna
bis p
rodu
cts i
t pro
vide
s (se
e C
3.1(
a))
incl
udin
g th
e fo
llow
ing?
Iden
tific
atio
n of
eac
h ca
nnab
is a
nd c
anna
bis-
deriv
ed p
rodu
ct it
pr
ovid
es is
pro
vide
d by
a c
o-ow
ned
oper
atio
n or
from
an
oper
atio
n th
at is
not
co-
owne
d; o
r
Info
rmat
ion
to in
dica
te id
entif
icat
ion
of th
e cu
ltiva
tor,
proc
esso
r, m
anuf
actu
rer a
nd/o
r ven
dor o
f eac
h ca
nnab
is p
rodu
ct, i
f pro
duce
d by
an
oper
atio
n th
at is
not
co-
owne
d?
☐
☐
☐
C3.
1(b)
(4) •
Can
nabi
s pro
visi
on r
estr
ictio
ns –
If th
e op
erat
ion
is su
bjec
t to
rest
rictio
ns o
n th
e pr
ovis
ion
of c
anna
bis,
such
as l
imita
tion
rega
rdin
g w
hat
empl
oyee
s may
and
may
not
pro
vide
var
ious
can
nabi
s pro
duct
s to
com
plia
nt
indi
vidu
als o
r lim
itatio
ns o
n w
hich
com
plia
nt in
divi
dual
s may
or m
ay n
ot
obta
in sp
ecifi
c pr
oduc
ts, d
oes i
t hav
e su
ffici
ent e
vide
nce
to sh
ow th
at it
is in
co
mpl
ianc
e?
☐
☐
☐
C3.
2(a)
• C
anna
bis p
rodu
ct a
cqui
sitio
n –
If th
e op
erat
ion
rece
ives
can
nabi
s pr
oduc
ts fr
om o
ne o
r mor
e cu
ltiva
tion,
pro
cess
ing,
or m
anuf
actu
ring
oper
atio
n, o
r fro
m o
ne o
r mor
e ve
ndor
s, h
as it
est
ablis
hed
and
impl
emen
ted
polic
ies f
or th
e ac
quis
ition
of c
anna
bis o
r can
nabi
s-de
rived
pro
duct
that
are
co
mpl
iant
with
any
regu
latio
n in
the
juris
dict
ion
it op
erat
es, i
nclu
ding
pol
icie
s on
the
follo
win
g?
Lo
catio
ns fo
r rec
eipt
of c
anna
bis p
rodu
cts;
Sche
dulin
g of
del
iver
ies t
o be
mad
e by
eith
er v
endo
rs w
ith sp
ecifi
c ap
poin
tmen
ts, o
r by
esta
blis
hing
ope
n ve
ndin
g tim
es, d
urin
g w
hich
an
y ve
ndor
may
mak
e a
deliv
ery
with
out a
spec
ific
appo
intm
ent;
and
A
ppro
pria
te p
ract
ices
for v
endo
rs a
nd c
ultiv
atio
n, p
roce
ssin
g, o
r m
anuf
actu
ring
oper
atio
n w
ith re
gard
to c
ultiv
atio
n pr
actic
es,
proc
essi
ng o
r man
ufac
turin
g pr
actic
es, p
acka
ging
and
/or l
abel
ing,
ch
emic
al a
naly
sis,
or a
ppro
pria
te tr
ansp
orta
tion
cond
ition
s (su
ch a
s re
frige
ratio
n).
☐
☐
☐
SAMPLE
C3.
2(b)
(1) •
Can
nabi
s pro
duct
rec
ords
– D
oes t
he o
pera
tion
mai
ntai
n ad
equa
te re
cord
s of e
ach
rece
ipt o
f can
nabi
s pro
duct
, inc
ludi
ng th
e fo
llow
ing?
The
nam
e (o
r ide
ntifi
catio
n) o
f the
cul
tivat
ion,
pro
cess
ing,
or
man
ufac
turin
g op
erat
ion
or v
endo
r pro
vidi
ng th
e ca
nnab
is p
rodu
ct;
A
des
crip
tion
of th
e ca
nnab
is p
rodu
ct o
f suf
ficie
nt sp
ecifi
city
; and
A st
atem
ent o
f the
qua
ntity
of e
ach
cann
abis
pro
duct
?
☐
☐
☐
C3.
2(b)
(2),
(3) •
Can
nabi
s pro
duct
rec
ords
– If
the
oper
atio
n is
a st
oref
ront
, do
es it
hav
e po
licie
s and
pro
cedu
res i
n pl
ace
that
min
imiz
e th
e de
liver
y of
pr
oduc
ts a
t tim
es a
nd in
loca
tions
whe
re c
ompl
iant
indi
vidu
als a
re p
rese
nt
(spa
ce a
llow
ing)
? D
oes i
t inf
orm
all
oper
atio
ns a
nd v
endo
rs o
f suc
h po
licie
s?
☐
☐
☐
C3.
3(a)
• C
anna
bis i
nfor
mat
ion
– D
oes t
he o
pera
tion
have
suffi
cien
t ev
iden
ce th
at a
ny in
form
atio
n it
prov
ides
, whe
ther
writ
ten
or v
erba
l, ab
out t
he
iden
tity,
qua
lity,
and
cul
tivat
ion
cond
ition
s of c
anna
bis i
s acc
urat
e?
☐
☐
☐
C3.
3(b)
(1),
(2),
& (3
) • C
anna
bis p
rodu
ct te
stin
g –
If th
e op
erat
ion
cond
ucts
te
stin
g on
can
nabi
s pro
duct
s doe
s it p
rope
rly d
iscl
ose
the
exte
nt a
nd ty
pe o
f te
stin
g it
cond
ucts
, or c
ause
s to
have
con
duct
ed, o
n th
e ca
nnab
is it
pro
vide
s, in
clud
ing
the
follo
win
g?
Th
e ty
pe o
f tes
t or e
xam
inat
ion
used
, if a
ny, t
o de
term
ine
the
parti
cula
r stra
in o
r cul
tivar
of e
ach
lot o
f can
nabi
s pro
vide
d;
W
heth
er o
r not
the
cann
abis
pro
vide
d is
test
ed to
det
erm
ine
the
quan
titat
ive
leve
ls o
f con
stitu
ents
and,
if so
, the
type
of t
estin
g us
ed;
and
W
heth
er o
r not
the
cann
abis
pro
vide
d is
test
ed to
det
erm
ine
the
abse
nce
or p
rese
nce
of sp
ecifi
c cl
asse
s of p
oten
tial c
onta
min
ants
an
d, if
so, t
he ty
pe o
f tes
ting
used
for a
ny o
f the
follo
win
g:
pest
icid
es, y
east
s and
mol
ds, o
r oth
er m
icro
biol
ogic
al c
onta
min
ants
.
☐
☐
☐
SAMPLE
C3.
3(b)
(4) •
Can
nabi
s pro
duct
test
ing
– If
the
oper
atio
n co
nduc
ts te
stin
g on
th
e pr
oduc
ts it
pro
vide
s, do
es it
hav
e si
gnifi
cant
evi
denc
e th
at th
e in
form
atio
n re
quire
d to
be
disc
lose
d is
mad
e av
aila
ble
at e
ach
phys
ical
faci
lity
mai
ntai
ned
by a
stor
efro
nt d
istri
butio
n op
erat
ion
via
one
or m
ore
of th
e fo
llow
ing
met
hods
? Po
stin
g re
adily
vis
ible
sign
age;
Prov
idin
g pr
inte
d ha
ndou
ts;
Po
stin
g on
any
web
site
at w
hich
pro
duct
s are
ava
ilabl
e fo
r ord
erin
g an
d pu
rcha
se; o
r
Post
ing
the
info
rmat
ion
so th
at c
ompl
iant
indi
vidu
als w
ill se
e th
e in
form
atio
n pr
ior t
o or
derin
g or
pur
chas
ing
prod
ucts
?
☐
☐
☐
C3.
3(c)
• C
anna
bis-
deri
ved
prod
uct i
nfor
mat
ion
– Is
the
info
rmat
ion
prov
ided
by
the
oper
atio
n ab
out t
he c
anna
bis-
deriv
ed p
rodu
cts i
t pro
vide
s av
aila
ble
in a
man
ner t
hat i
s com
plia
nt w
ith in
form
atio
n re
quire
d by
the
juris
dict
ion
it op
erat
es?
Doe
s the
ope
ratio
n ha
ve si
gnifi
cant
evi
denc
e th
at th
e in
form
atio
n pr
ovid
ed is
as f
ollo
ws?
Acc
urat
ely
conv
eyed
thro
ugh
labe
ling
or o
ther
acc
urat
e m
arki
ngs o
r co
mm
unic
atio
ns, i
n a
man
ner c
ompl
iant
with
all
rele
vant
re
quire
men
ts;
and
If
prov
ided
by
anot
her m
anuf
actu
rer,
the
info
rmat
ion
is a
s pro
vide
d by
eac
h pr
oduc
t’s m
anuf
actu
rer w
ithou
t mod
ifica
tion
to th
e la
belin
g or
oth
er in
form
atio
n.
Doe
s the
ope
ratio
n ha
ve p
olic
ies a
nd p
roce
dure
s in
plac
e to
seek
cla
rific
atio
n or
cor
rect
ion
of a
ny in
form
atio
n pr
ovid
ed b
y a
man
ufac
ture
r tha
t it h
as re
ason
to
bel
ieve
may
not
acc
urat
e?
☐
☐
☐
C3.
4(a)
• C
anna
bis p
rodu
ct r
ecal
ls –
Doe
s the
ope
ratio
n ha
ve a
n es
tabl
ishe
d po
licy
for c
omm
unic
atin
g a
reca
ll of
a c
anna
bis p
rodu
ct th
at h
as b
een
show
n to
pre
sent
a re
ason
able
or a
rem
ote
prob
abili
ty th
at th
e us
e of
, or e
xpos
ure
to,
the
prod
uct c
ould
cau
se se
rious
adv
erse
hea
lth c
onse
quen
ces,
or c
ould
cau
se
tem
pora
ry o
r med
ical
ly re
vers
ible
adv
erse
hea
lth c
onse
quen
ces?
Doe
s tha
t po
licy
incl
ude
the
follo
win
g?
A
mec
hani
sm to
con
tact
all
cust
omer
s who
hav
e, o
r cou
ld h
ave,
ob
tain
ed th
e pr
oduc
t fro
m th
e op
erat
ion,
incl
udin
g in
form
atio
n on
th
e po
licy
for r
etur
n or
des
truct
ion
of th
e re
calle
d pr
oduc
t;
A m
echa
nism
to c
onta
ct th
e cu
ltiva
tion,
pro
cess
ing
,or
man
ufac
turin
g op
erat
ion
or v
endo
r whi
ch su
pplie
d th
e pr
oduc
t; an
d
Com
mun
icat
ion
and
outre
ach
via
med
ia, a
s nec
essa
ry a
nd
appr
opria
te.
☐
☐
☐
SAMPLE