OnlineUniversity_Pharmaceuticals-ComplianceandAudits.pdf

Pharmaceuticals: Compliance and Audits Supplementary Materials

Table of Contents Tips and Best Practices ................................................................................................................................... 1 Acronyms Guide .............................................................................................................................................. 2 References and Resources .............................................................................................................................. 4 Course Storyboard .......................................................................................................................................... 6

RAPS Online University | Pharmaceuticals: Compliance and Audits 1

TIPS AND BEST PRACTICES SYSTEM REQUIREMENTS

Web Version o Internet Explorer 8 is the preferred browser; participants can also use a current version of Firefox or Safari o Google Chrome is not a supported browser o Flash 9 is a common plug-in used in the courses and can be downloaded for free at www.adobe.com o Participants may need to disable their browsers pop-up blocker; instructions are provided on the course launch page

iPad Version o Download the free Articulate Mobile Player App from the App Store o Content in this format can be made available for offline viewing; before attempting to download the course to your iPad, ensure that

you have enough available storage space on your device. This information is provided on the course launch page.

USING ONLINE UNIVERSITY There are three orientation videos accessible from the Welcome screen, which review the features and functions of the course players and online system to help maximize and simplify your learning experience. It is also a good idea to read the Online University FAQs accessible in the HELP section. MAXIMIZE YOUR LEARNING Courses are organized into lessons to let you to fit in learning as your schedule permits. For optimal comprehension and retention, however, try to complete at least 1530 minutes of content at a time. Lesson title pages offer a convenient point to put down the course and the bookmarking feature automatically saves your progress. To ensure bookmarks save properly, exit the course player and let the SCORM Controller window close by itself (Web version) or close the Articulate App (iPad version). Bookmarks do not transfer between Web and iPad versions. It is also helpful to have this packet of supplementary materials handy when going through the content. The course Storyboard is intended to be an organizational tool for your own note-taking and not the full course text; printable full text is not available. Some of the Storyboard images may appear blank or incomplete because the multimedia used cannot be exported to other formats. TAKING THE FINAL ASSESSMENT

30 questions a mix of true/false, multiple choice and/or numeric test items 80% passing score Untimed completion An answer key is not provided Cannot save and return No limit on the number of attempts allowed Each time the assessment is taken some of the questions will change


ACRONYMS GUIDE ADE Adverse Drug Events ADR Adverse Drug Reaction AE Adverse Events ANDA Abbreviated New Drug Application API Active Pharmaceutical Ingredient ARTG Australian Register of Therapeutic Goods BGTD Biologics and Genetic Therapies Directorate BIMO Bioresearch Monitoring Program BLA Biologic License Applications CAPA Corrective and Preventive Actions CAR Corrective Action Requests CAT Committee for Advanced Therapies CBER Center for Biologics Evaluation and Research CDER Center for Drug Evaluation and Research CDRH Center for Devices and Radiological Health CFR Code of Federal Regulations CFR Code of Federal Regulations CFSAN Center for Food Safety and Applied Nutrition CGMP Current Good Manufacturing Practices CHMP Committee for Medicinal Products for Human Use CMC Chemistry, Manufacturing and Controls CP Compliance Program CPP Critical Process Parameters CQA Critical Quality Attributes CRO Contract Research Organizations CTA Clinical Trial Application CVMP Committee on Medicinal Products for Veterinary Use DEA Drug Enforcement Agency DMF Document Master File DMPQ Division of Manufacturing and Product Quality

DOD Department of Defense DQR Drug Quality Reports EC European Commission EEA European Economic Area

EFPIA European Federation of Pharmaceutical Industries and Associations EFTA European Free Trade Association EIR Establishment Inspection Report EMA European Medicines Agency EN European Standards EPA Environmental Protection Agency EV Effectiveness Verification FD&C Act Food, Drug and Cosmetic Act FDA US Food and Drug Administration FDAAA Food and Drug Administration Amendments Act FDAMA Food and Drug Administration Modernization Act FDLI Food and Drug Law Institute GAO Government Accountability Office GCP Good Clinical Practice GDP Good Distribution Practice GLP Good Laboratory Practice GMP Good Manufacturing Practice (US) GMP Good Manufacturing Principle (Australia) HC Health Canada HHS US Department of Health and Human Services HIPAA Health Insurance Portability and Accountability Act HMA Heads of Medicines Agencies HPFBI Health Products and Food Branch Inspectorate ICH International Conference on Harmonization IFPMA International Federation of Pharmaceutical


Manufacturers & Associations IND Investigational New Drugs IOM Investigations Operations Manual IRC International Regulatory Cooperation ISO International Organization for Standardization ITF Innovation Task Force

JAAME Japan Association for the Advancement of Medical Equipment JPMA Japan Pharmaceutical Manufacturers Association MAA Marketing Authorization Application MAH Marketing Authorization Holder MHLW Japanese Ministry of Health, Labour and Welfare MOU Memorandum of understanding MRA Mutual Recognition Agreement NAI No Action Indicated NDA New Drug Application NDS New Drug Submission NGO Non-Governmental Organization NiBio National Institute of Biomedical Innovation NIHS National Institute of Health Sciences NME New Molecular Entities OECD Organization for Economic Cooperation and Development OMQ Office of Manufacturing Quality OOS Out-of-Specification OPSR Organization for Pharmaceutical Safety and Research ORA Office of Regulatory Affairs OSHA Occupational Safety and Health Administration OTC Over-the-Counter PAI Pre-Approval Inspection PAL Pharmaceutical Affairs Law PAT Process Analytical Technology PDMA Prescription Drug Marketing Act

PhRMA Pharmaceutical Research and Manufacturers of America PIC/S Pharmaceutical Inspection Cooperation Scheme PMDA Pharmaceuticals and Medical Devices Agency PMDEC Pharmaceuticals and Medical Devices Evaluation Center PPE Personal Protective Equipment QMS Quality Management Systems QP Qualified Person QRB Quality Review Board QS Quality System QSR Quality System Regulation SMON Subacute Myelo-Optical-Neuropathy SOX Sarbanes-Oxley SPC Statistical Process Control TGA Therapeutic Goods Administration TPD Therapeutics Products Directorate UL Underwriters Laboratories US United States USDA US Department of Agriculture USP United States Pharmacopeia VAI Voluntary Action Indicated WHO World Health Organization


REFERENCES AND RESOURCES Lesson 1

EMA. Committee for Medicinal Products for Human Use (CHMP) website. European Medicines Agency (EMA) website. Heads of Medicine Agencies (HMA) website. Ministry of Health, Labour and Welfare. (4) Drugs - Approval and Licensing System for Drugs, Quasi-drugs and Cosmetics National Institute of Health Sciences website. Pharmaceutical Inspection Cooperation Scheme. Pharmaceuticals and Medical Devices Agency (PMDA) website. TGA. Australian register of therapeutic Goods (ARTG) website. TGA. Office of Manufacturing Quality. Therapeutic Goods Administration (TGA) website. US FDA. CP 7346.832CP 7346.832Pre-approval Inspections/Investigations. 5 April 2005. US FDA. CP 7346.843CP 7346.843 Postapproval Audit Inspections. US FDA. CP 7356.002CP 7356.002 Drug Manufacturing Inspections. 1 February 2002. US FDA. Remarks by Margaret A. Hamburg, M.D. Commissioner of Food and Drugs on "Effective Enforcement and Benefits to Public Health--

Effective Enforcement and Benefits to Public Health" at Food and Drug Law Institute. 6 August 2009. Lesson 2

7356.002M, Inspections of Licensed Biological Therapeutic Drug Products Chesney, David L. Management Controls for GMP Compliance Pharmaceutical Technology April 2005. P 64-72 Compilation of Community Procedures on Inspections and Exchange of Information: Guideline on Training and Qualifications of GMP Inspectors

(Compliance and Inspection). European Medicines Agency. EMA/INS/GMP/321252/2012 Rev 14. 25 May 2012. Page 55-60. Conan-Conan, Michelle. [October 2011] EMA-FDA Joint GMP and GCP Inspection Pilot Programs Dodsworth, N; Hubby S. Global Forum. Comparison between the FDA and European Inspection Process: Joint EMA-FDA GCP Inspections. FDA. CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections. 2 June 2007. FDA. Investigations Operations Manual. FDA - TGA FDA's Pharmaceutical Inspectorate Searches for Higher Ground, Thomas, P. Pharma Manufacturing FDA's Pharmaceutical Inspectorate. Robert Coleman. National Expert Drug Investigator. Food and Drug Administration. Certification.

Background. Certification ... asq.org/fdc/2006/02/fda-s-pharmaceutical-inspectorate.ppt GMP Inspection Cooperation between EMA and FDA GMP Inspection Cooperation between Canada Health Protection Branch and FDA GMP Inspection Cooperation between Japan and FDA


ISO 9001:2008. Quality Management Systems Requirements. ISO 9000:2001 Quality Management Systems Requirements. Nazar, N., Schmidt, S. RA Focus Oct. 2011. Vol 16, No. 10 p. 23-28. PIC/S BLUEPRINT (Road Map 2015): PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME. PS/W 8/2005. 23 December 2005 US Department of Health & Human Services. HIPAA Enforcement. Writing An Effective 483 Response, Anita Richardson FDA

General Resources

Agrasala, Vinod. Assessment, Gap analysis and Audit! American Society for Quality. Quality Auditor Certification - Body of Knowledge. Boatman, J. QPharma. Introduction to Life Science Auditing. 2010. Deloitte. The Risk Intelligent chief audit executive - Mission possible. Risk Intelligence Series Issue No. 5. FDA. 21 CFR Part 820 - Quality System Regulation. FDA. Final Guidance for Industry and FDA Staff - General Principles of Software Validation. 11 January 2002. FDA. Guidance for Industry - Part 11, Electronic Records; Electronic Signatures Scope and Application. August 2003. FDA. Hazard Analysis and Critical Control Point Principles and Application Guidelines. FDA. Inspection Reference, Guides & Field Activities. FDA. Pharmaceutical CGMPs for the 21st Century - A Risk-Based Approach. September 2004. FDA. The FDA Enforcement Report.HIMA. Points to Consider When Preparing for an FDA Inspection under the Management Controls Subsystem.

6 October 1999. ICH. Q9 Quality Risk Management Institute of Internal Auditors. Practice Advisory 2010-2: Using the Risk Management Process in Internal Audit Planning, July 2009. Institute of Internal Auditors. The Role of Internal Auditing in Enterprise-wide Risk Management. 29 September 2004. International Society for Pharmaceutical Engineering. GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems. 2008. RAPS.

Fundamentals of EU Regulatory Affairs, 4th Edition. Rolli, Nancy. FDA. Role of Internal Auditing in GMP Management. Presented 14 May 2008. Swann, John P. FDAs Origin. 18 June 2009. Wilkenfeld, Jonathan. Rx Compliance Report. 7 September 2009.


COURSE STORYBOARD


Course Overview

Notes:

Learning Objectives

Notes:


Author Biographies

Notes:

References and Resources

Notes:


Lesson 1: Pharmaceutical Drug Compliance

Notes:

Introduction

Notes:


Lesson Objectives

Notes:

History of FDA

Notes:


FDAs Recent Enforcement Initiatives

Notes:

FDAs Current Initiatives

Notes:


Compliance Programs

Notes:

Preapproval Inspections/Investigations Compliance Program 7346.832

Notes:


Preapproval Inspection (PAI) Program Objectives

Notes:

Objective 1: Readiness for Commercial Manufacturing

Notes:


Objective 1(a)

Notes:

Objective 1(b)

Notes:


Objective 1(c)

Notes:

Objective 1(d)

Notes:


Objective 1(e)

Notes:

Objective 2: Conformance to Application

Notes:


Objective 3: Data Integrity Audit

Notes:

Postapproval Audit Inspections: Compliance Program 7346.843

Notes:


Types of Inspections

Notes:

Strategy for Inspections

Notes:


Audit Process

Notes:

Drug Manufacturing Inspections: Compliance Program 7356.002

Notes:


Scheme of Systems

Notes:

Inspection Approaches

Notes:


Comprehensive Inspection Coverage

Notes:

FDA Enforcement Actions

Notes:


FDA Enforcement Report

Notes:

Enforcement Report Definitions

Notes:


Current International Regulatory Body Compliance Enforcement Initiatives

European Union (EU)

Notes:


The Heads of Medicines Agencies

Notes:

The European Medicines Agency

Notes:


Good Laboratory Practice

Notes:

Good Manufacturing Practice

Notes:


Good Distribution Practice

Notes:

Role of the Compliance and Inspection Sector

Notes:


GMP Advice

Notes:

Innovation Task Force (ITF)

Notes:


GLP Inspections

Notes:

Laboratories Performing Nonclinical Safety Studies

Notes:


Guidance Related to GCP Implementation

Notes:

Mutual Recognition Agreements

Notes:


Canada

Notes:

Health Canada

Notes:


Good Clinical Practice

Notes:

Japan

Notes:


Japan

Notes:

GMP Compliance Inspection of Foreign Manufacturers

Notes:


GMP Inspection for Approval

Notes:

Scope of Drugs Subject to GMP Compliance Inspection

Notes:


Inspection Application Documents

Notes:

Inspection Fee

Notes:


The Pharmaceuticals and Medical Devices Agency

Notes:

Australia

Notes:


Australia

Notes:

Therapeutic Goods

Notes:


Control of Therapeutic Goods

Notes:

Office of Manufacturing Quality

Notes:


Lesson Summary

Notes:

Lesson 2: Pharmaceutical Drug Audits

Notes:


Introduction

Notes:

Lesson Objectives

Notes:


US Pharmaceutical Drug Inspections

Notes:

What is an Inspection?

Notes:


Investigations Operations Manual

Notes:

Establishment Inspections

Notes:


Pre-announcements

Notes:

Coordinating an Inspection

Notes:


Notice of Inspection

Notes:

Considerations During an FDA Inspection

Notes:


Inspection Walk-through

Notes:

Inspectional Approach

Notes:


System Inspection Coverage

Notes:

FDA Access to Records

Notes:


Closing Meetings and Reporting of Observations

Notes:

FDA Authority to Issue 483

Notes:


Difference Between a Form 483 and a Warning Letter?

Notes:

FDA Activities Following an Inspection

Notes:


Responding to a Form 483 / Warning Letter

Notes:

Drafting a Form 483/Warning Letter Response

Notes:


Additional Governing Agencies, Acts, Standards and Organizations

Notes:

General Discussion on International Market Audit Requirements

Notes:


Memoranda of Understanding and Other Cooperative Arrangements

Notes:

GMP Inspection Cooperation between the US, Canada, Australia and Japan

Notes:


International Guidance for Training and Qualification of GMP Inspectors

Notes:

EU

Notes:


Maintenance of Competence

Notes:

US: Training of Inspectors

Notes:


What is the curriculum?

Notes:

The Pharmaceutical Inspection Convention (PIC/S)

Notes:


Pharmaceutical Inspectorate as part of PIC/S

Notes:

Joint Audit Program

Notes:


Lesson Summary

Notes:

Lesson 3: Auditing Techniques and Tools

Notes:


Introduction

Notes:

Lesson Objectives

Notes:


Auditing as a Value Proposition

Notes:

Types of Audits

Notes:


Effectiveness Verification

Notes:

ISO 9000

Notes:


ISO 19011: General Guidelines for Quality and/or Environmental Management Systems Auditing

Notes:

Auditor Independence

Notes:


Auditing to a Standard or Regulation

Notes:

The Process Approach

Notes:


Other Approaches

Notes:

Preparing and Using an Audit Checklist

Notes:


Note-taking

Notes:

Questioning Techniques

Notes:


Preparing to Audit

Notes:

The Opening Meeting

Notes:


The Tour

Notes:

Audit Execution

Notes:


Evidence/Records

Notes:

Closing Meeting

Notes:


Audit Findings

Notes:

Types of Nonconformances

Notes:


Objective Evidence

Notes:

Documentation

Notes:


Common Mistakes

Notes:

Lesson Summary

Notes:


Closing Summary

Notes:

Proceed to Final Assessment

Notes:

Pharm-C&A_Course Packet CoverCourse Packet_Ph-C&A 3TUFDA - TGAU3T 3TUFDA's Pharmaceutical Inspectorate Searches for Higher Ground, Thomas, P. Pharma ManufacturingU3T

3TUGMP Inspection Cooperation between EMA and FDAU3TCourse OverviewLearning ObjectivesAuthor BiographiesReferences and ResourcesLesson 1: Pharmaceutical Drug ComplianceIntroductionLesson ObjectivesHistory of FDAFDAs Recent Enforcement InitiativesFDAs Current InitiativesCompliance ProgramsPreapproval Inspections/Investigations Compliance Program 7346.832Preapproval Inspection (PAI) Program ObjectivesObjective 1: Readiness for Commercial Manufacturing Objective 1(a)Objective 1(b)Objective 1(c)Objective 1(d) Objective 1(e)Objective 2: Conformance to Application Objective 3: Data Integrity Audit Postapproval Audit Inspections: Compliance Program 7346.843Types of InspectionsStrategy for InspectionsAudit ProcessDrug Manufacturing Inspections: Compliance Program 7356.002Scheme of Systems Inspection ApproachesComprehensive Inspection CoverageFDA Enforcement ActionsFDA Enforcement ReportEnforcement Report DefinitionsCurrent International Regulatory Body Compliance Enforcement InitiativesEuropean Union (EU)The Heads of Medicines Agencies The European Medicines Agency Good Laboratory PracticeGood Manufacturing PracticeGood Distribution PracticeRole of the Compliance and Inspection SectorGMP AdviceInnovation Task Force (ITF)GLP InspectionsLaboratories Performing Nonclinical Safety StudiesGuidance Related to GCP Implementation Mutual Recognition Agreements CanadaHealth CanadaGood Clinical PracticeJapanJapanGMP Compliance Inspection of Foreign Manufacturers GMP Inspection for ApprovalScope of Drugs Subject to GMP Compliance Inspection Inspection Application DocumentsInspection Fee The Pharmaceuticals and Medical Devices Agency AustraliaAustraliaTherapeutic GoodsControl of Therapeutic GoodsOffice of Manufacturing QualityLesson SummaryLesson 2: Pharmaceutical Drug AuditsIntroductionLesson ObjectivesUS Pharmaceutical Drug InspectionsWhat is an Inspection?Investigations Operations ManualEstablishment InspectionsPre-announcementsCoordinating an InspectionNotice of InspectionConsiderations During an FDA InspectionInspection Walk-throughInspectional ApproachSystem Inspection Coverage FDA Access to RecordsClosing Meetings and Reporting of ObservationsFDA Authority to Issue 483Difference Between a Form 483 and a Warning Letter? FDA Activities Following an Inspection Responding to a Form 483 / Warning LetterDrafting a Form 483/Warning Letter ResponseAdditional Governing Agencies, Acts, Standards and OrganizationsGeneral Discussion on International Market Audit RequirementsMemoranda of Understanding and Other Cooperative ArrangementsGMP Inspection Cooperation between the US, Canada, Australia and Japan International Guidance for Training and Qualification of GMP InspectorsEUMaintenance of CompetenceUS: Training of InspectorsWhat is the curriculum?The Pharmaceutical Inspection Convention (PIC/S)Pharmaceutical Inspectorate as part of PIC/SJoint Audit ProgramLesson SummaryLesson 3: Auditing Techniques and ToolsIntroductionLesson ObjectivesAuditing as a Value PropositionTypes of AuditsEffectiveness VerificationISO 9000ISO 19011: General Guidelines for Quality and/or Environmental Management Systems AuditingAuditor IndependenceAuditing to a Standard or RegulationThe Process ApproachOther ApproachesPreparing and Using an Audit ChecklistNote-takingQuestioning TechniquesPreparing to AuditThe Opening MeetingThe TourAudit ExecutionEvidence/RecordsClosing MeetingAudit FindingsTypes of NonconformancesObjective EvidenceDocumentationCommon MistakesLesson SummaryClosing SummaryProceed to Final Assessment

OnlineUniversity_Pharmaceuticals-ComplianceandAudits.pdf

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