Performing Multiple Regulatory Requirements within a ... · required infrastructure ......
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Performing Multiple Regulatory Requirements within a Program Such as GMP, GLP, GCP, Medical Devices, and/or Controlled Substances
Transcript of Performing Multiple Regulatory Requirements within a ... · required infrastructure ......
Performing Multiple Regulatory Requirements within a Program Such as GMP, GLP, GCP, Medical Devices, and/or Controlled Substances
Performing Multiple Regulatory Requirements within a Program Such as GMP, GLP, GCP, Medical Devices, and/or Controlled SubstancesPharma work may require multiple GXP programs GMPGLPDEAMedical DeviceGCP
These may include special training practices, documentation efforts, facility and equipment processes, interactions from one regulation to another as well as the monitoring of record keeping and reporting.
Attempting to run multiple programs may fail if:Duplicate procedures are provided with conflicting
requirements
Overview
• Establishing a Quality Management System• The Umbrella of the QMS
• Reinforcement of Top Management• Continued Support
• Developing a Quality Team of All Stakeholders• Providing feedback to groups
Quality Management System
Defines the Organization
Establishes Leadership and Management
• Senior management acting as role models for how all employees should work
Quality Management System Team
ManagementManagement
Quality AssuranceQuality
Assurance
Project TeamProject Team
Certified Quality System
• A quality management system (QMS) is essential in today’s market
• Strong marketing tool • Limits competition due to cost and
required infrastructure• Provides clients with assurances that
systems are under control• Focuses staff on improvement,
compliance, and customer satisfaction
Integration of Multiple QMSs under ISO 9001
ISO 9001
ISO 13485GLP 58, 160
GMP 211
NQA1
17025
17020NELAC (EPA)
DOE/
DOD
AR 50‐6
USDA
DEA
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Good Manufacturing Practice (cGMP)
21 CFR Part 210 –Current GMP in Manufacturing, Processing, Packing, or Holding of
Drugs; General;
21 CFR Part 211 –Current GMP Practice in Finished
Pharmaceuticals
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21 CFR Part 11 Compliance for
Software
Good Laboratory Practice (GLP)
FDA (Food & Drug Administration; 40 CFR Part 58)• FDA is proposing to amend regulations to require a complete quality system approach
• Announced Aug 2016
EPA FIFRA (Federal Insecticide, Fungicide & Rodent Act; 40 CFR Part
160)
EPA TSCA (Toxic Substance Control Act;
40 CFR Part 792)
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Medical Devices
ISO 13485:2003 Medical Devices –Quality Management• Quality Requirement Manual (QRM) Revision 2
• Project Quality Plans
21 CFR Part 820 Food And Drug AdministrationDepartment Of Health And
Human Services Subchapter H‐‐Medical Devices
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ISO 9001:2015 Quality SystemControlled notebooks
Controlled procedures
Quality Records –Archived Division 01
Traceability
Software and Hardware controls
Design control
Quality Project Plan
Training
Corrective Actions (QRS)
Internal Audits
Drug Enforcement Agency (DEA) (Department of Justice)
• All projects involving controlled substances requires a DEA license for either manufacturing or research
• Licenses maintained by the Legal Department
DEA (Drug Enforcement Agency)
• Traceability• Audit trail• Special Reporting• Secure & Limited Access to drug
• Accountability• DEA registration
Pharmaceutical programs may
involve controlled substances requiring
DEA Research/Manufacturing
Research
• Traceability• Zero tolerance• Locked cabinet• Limited access• Signed DEA access
• ISO Requirements• DEAAudit Potential• Surveillance to control• DEA Training• Biennial Inventory
Manufacturing
• Traceability• Zero tolerance• Regulation Safe• Limited access• Signed DEA access
• ISO Requirements• DEA Audit Definite• ARCOS Requirements• DEA Training• Biennial Inventory• EOY Inventory
Integration of Multiple QMSs under ISO 9001
ISO 9001
ISO 13485
GLP 58, 160
GMP 211
17025NELAC (EPA)
USDA
DEA
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The ISO Umbrella
The ISO 9001 is the umbrella that allows the organization to meet other regulatory
requirements.
Procedures required by
other program are already identified in the ISO 9001
SOPs
ISO 9001:2015 Minimums• The ISO Procedures on all Projects for all Division 01 Staff
• Document Control• Forms, TAPs, Plans, Notebooks
• Data Control and Reporting• A minimum for all reports to paying clients
• Training• Some regulatory groups have zero tolerance for delinquent training i.e. FDA
• Calibration• Of any measurement activity
• Evaluate Risks
• Approved Supplier List• For all class 1 items• At the manufacturing facility not the distributor
• Nonconforming processes, procedures• If we do not document the problem and corrective action the auditor/client will
define as a finding
ISO 9001
• Establishes criteria for a quality management system
• Used across all industries, organizations and countries
• Based on a number of quality principles • Customer focus• Leadership• Engagement of people• Process approach• Improvement• Evidenced-based decision making• Relationship management
ISO 9001
cGMP21 CFR Part 211
GLP21 CFR Part 5840 CFR Part 160
GCP21 CFR Part 312
Medical DeviceISO 13485
21 CFR Part 820
DEA21 CFR Part
1300
QA for GMPGMP Recalls
OOSValidation
QualificationBSE/TSEStability
Study Dev.Study Director
ProtocolFinal Report
QAUMaster Schedule
Clinical StudyCRO
RandomizationMonitor
Human SubjectIRB
Bioavailability
Device RecordDesign ReviewDesign Transfer
Cert. MarkInvestigationInformed Consent
Form 222Inventory
Use & TrackingACROS
EOY InventoryQuota
Organization/ PersonnelFacilities
EquipmentRisk
Document ControlPurchasing
CAPARecords and Reports
Develop The Quality Team (Quality Circle)
Monitoring and Measurement
Preparation/Review/Approval of Proposals and Contracts
Purchasing
Control of Customer‐Supplied Items
Handling, Storage, Packaging Protection, and Delivery of Items
Customer Feedback/Complaints
Internal/External Quality Audits
Nonconforming Material
Quality System Trending
CAPA Program
Quality Management System
Document Control
Organization and Responsibility
Evaluation of Risk Opportunities
Computer Hardware/Software
Management Review
Qualification and Training
Laboratory Notebooks Requirements
Data Control and Reporting
Storage and Maintenance of Quality Records
Control of Measuring and Test Equipment
Risk Evaluation Required in 9001, GMP, Medical Device, DEA, but beneficial in other regs
• One time documentsOnce the key SOPs are developed the required procedures may apply to
multiple programs
• Avoids the need for multiple revisionsWhen revised, the revision is one time.
• Titles of the main SOP are general to other requirements
Most programs require 70 to 90% of the SOPs identified
• Sub SOPs as needed may be added to the QMS to avoid duplicate procedures
Provide the main SOPs as a controlled document for all
Audits
MANAGEMENT REVIEW
• Management review allows the QMS for Trending and Reporting
• Identify a Quality Program within your CAPA System• This allows each program
to be trended by defect code
• Minimizes efforts of multiple programs for management review
Document/Change Control
Involves initial request for all documents • Revisions needed during review• Notebooks• Protocols• Plan• Form
Change Control (GMP/Medical Device/GCP)• Reason for Change• Documents affected• QA Approval prior to change• Follow up and Close out of Change
Quality is not Free!!Creation of initial processes
Preparing Standard Operating Procedures
Review and Approvals
Initial and continual training
Quality Assurances Plans for projects
Documentation
Calibration and documentation of compliance
Demonstration of competency
25 to 45 external client or regulatory audits per year
Archiving results and studies
Benefits of Quality?
Each audit has the umbrella procedures for ease
Added Program procedures are effective
Continual Improvements due to the additional audits
Repetitiveness throughout all programs
Efficient Systems
Compliance
Continuous training repetitiveness
Customer retention
New Customers Growth for different programs
Leadership and Management
• All ISO programs going through revisions• Top Management shall demonstrate leadership and commitment by….
• GLP• Testing facility management shall…..
• Medical Device• Executive responsibility shall ensure…….
• DEA• Reports to highest level of management…..
Most programs require
Management as leaders
and continual support of the program
LEADERSHIP AND
MANAGMENT
COMMITMENT TO QUALITY
AND INTEGRITYLEADS
PROJECTS
TOP MANAGEMENT
CULTURE AND FINANCE
ACCOUNTABLE
DECISION AND PROBLEM SOLVERS
PERFORMANCE AND INTEGRITY MANAGEMENT
How to Initiate a New QMS to current programs
Establish the QMS elements and procedures
Develop SOPs and review for the QMS elements
Train to the new QMS SOPs and explain the tiered effects
Incorporate the new QMS by merging the existing programs:• Review each program SOP and delete duplicate SOPs to the new SOP• Check remaining program SOPs for reference to those duplicates and reference new SOP replacing the duplicate
• Program Quality Program Plans are helpful to reference all documents associated
• Train to the completed programs• Reinforce the new references in existing documents
Adding a New Program to the QMS
Consider a Quality Program Plan (QPP)• The plan identifies the minimal program elements• The QPP will identify current SOPs developed in the umbrella QMS
Establish additional elements required for the new program
Review the QPP to reference the new SOPs for the new program
Train staff involved in the new program to• QPP and emphasize reference documents• New documents for the new program
Utilize this process for program auditors
