The Certified Pharmaceutical GMP Professional Handbook 2nd Edition by Mark Allen Durivage, ISBN-13: 978-0873899338

The Certified Pharmaceutical GMP Professional Handbook 2nd Edition by Mark Allen Durivage, ISBN-13: 978-0873899338

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• Publisher: ‎ ASQ Quality Press; Second edition (May 26, 2016)
• Language: ‎ English
• 516 pages
• ISBN-10: ‎ 0873899334
• ISBN-13: ‎ 978-0873899338

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight.

This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

Table of Contents:

Title Page
CIP Data
Table of Contents
List of Figures and Tables
Acronyms and Abbreviations
Preface
Acknowledgments
Part I: Regulatory Agency Governance
Chapter 1: Global Regulatory Framework
United States Federal Statutes Relevant to Pharmaceuticals
The Administrative Procedure Act
United States Federal Food, Drug, and Cosmetic Act
United States Public Health Service Act
The Virus-Serum-Toxin Act
European Union’s Legal System Relevant to Pharmaceuticals
Japan’s Legal System Relevant to Pharmaceuticals
China’s Legal System Relevant to Pharmaceuticals
India’s Legal System Relevant to Pharmaceuticals
Chapter 2: Regulations and Guidances
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Health Canada
World Health Organization (WHO)
International Conference on Harmonization
European Medicines Agency (EMA)
The United States Food and Drug Administration
Therapeutic Goods Administration (TGA)
United States Department of Agriculture (USDA) 9 CFR—Animals and Animal Products
USDA Veterinary Service Memorandum No. 800.65
International Pharmaceutical Excipients Council
Japanese Ministry of Health, Labour, and Welfare (MHLW)
Chapter 3: Mutual Recognition Agreements
Mutual Recognition Agreements
MRAs Established by the European Union and Partner Countries
Key Elements of Mutual Recognition Agreements
Pharmaceutical Inspection Co-operation Scheme
Chapter 4: Regulatory Inspections
Inspection Authority
Types of Inspections
Sharing of Inspection Findings
Inspections of Foreign Drug Manufacturers
Reviewing Documents
Validation
Cultural Aspects
Documentation of Violations of cGMPs
Inspection Techniques
Inspection Process of a U.S. Firm
Chapter 5: Enforcement Actions
Types of Enforcement Actions
Notice of Observations/Violations
FDA Untitled Letters
Warning Letters
Product Seizures
Injunctions
Loss of Marketing License
Loss of Establishment License
Debarment
Voluntary Actions
Chapter 6: Regulatory Agency Reporting
Planned Changes
Evaluating Post-Marketing Changes
Technical Assessment
Analytical Assessment
Equivalence Assessment
Adverse Effect
Reporting Strategy
Regulatory Reporting Requirements
Planned Changes
Unplanned Events
Chapter 7: Site Master File (SMF), ValidationMaster Plan (VMP), Drug Master File(DMF), and Site Refe
Site Master File
Content of Site Master Files
Validation Master Plan (VMP) and Master Validation Plan (MVP)
Drug Master File
Types of Drug Master Files
Changes to Drug Master Files
Preparing a Site Master File (SMF)
Content of Site Master File
Appendixes
Part II: Quality Systems
Chapter 8: Quality Management System
Establishing a Quality Management System
Quality Management System Principles
Quality Management System Practices
Audits, Reviews, and Assessments
ICH Q10: Pharmaceutical Quality System
ICH Q10 Objectives
Enablers: Knowledge Management and Quality Risk Management
Design and Content Considerations, Quality Manual
Management Responsibility
Management Commitment
Quality Policy
Quality Planning
Resource Management
Internal Communication
Management Review
Management of Outsourced Activities and Purchased Materials
Management of Change in Product Ownership
Continual Improvement of Process Performance and Product Quality
Life Cycle Stage Goals
Pharmaceutical Quality Management System Elements
Continual Improvement of the Pharmaceutical Quality System
Management Review
Monitoring of Internal and External Factors
Outcomes of Management Review and Monitoring
Conclusion
Chapter 9: Quality Unit (Site) Management
Qualified Person
Responsibilities of the Qualified Person
Specific Requirements for the Qualified Person
Certification of Batch Release
Maintenance of a Quality Management System
The Qualified Person and the Product Quality Review
The Qualified Person and Reference and Retention Samples
External Qualified Persons
Delegation of Tasks/Absence of a Qualified Person
Organizational Duties to Be Established by the Companyof the Qualified Person
Annex 16 to the EU Guide to GMP Certification and Batch Release
Principle
Introduction
General
Batch Testing and Release of Products Manufactured in the EC/EEA
Batch Testing and Release of Products Imported from a Third Country
General
Location of Sampling for Testing in EC/EEA
Batch Testing and Release of Products Imported from a Third Country with EC MRA
Routine Duties of a Qualified Person
Chapter 10: Risk Management
General Quality Risk Management Process
Risk Assessment
Risk Control
Risk Communication and Risk Review
Risk Management Methodology
Integration into Industry and Regulatory Operations
Methods and Tools
Basic Risk Management Facilitation Methods
Failure Mode and Effects Analysis
Failure Mode, Effects, and Criticality Analysis
Fault Tree Analysis
Hazard Analysis and Critical Control Points
Hazard Operability Analysis
Preliminary Hazard Analysis
Risk Ranking and Filtering
Supporting Quality and Statistical Tools
Chapter 11: Training and Personnel Qualifications
Job-Specific Training
Good Manufacturing Practices Training
Training Effectiveness
Employee Qualifications
Documentation of Training
Employee Proficiency
Chapter 12: Change Control and Management
Chapter 13: Investigations and Corrective and Preventive Action (CAPA)
CAPA Process
General Considerations for CAPA
CFR 211.192 Production Record Review
FDA 21 CFR 820.100 Corrective and Preventive Action
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
FDA Guide to Inspections of Quality Systems
Chapter 14: Audits and Self-Inspections
Audit Types
First-Party Audits
Audit Process
Written Procedure
Audit Schedule
Qualified, Independent Auditors
Analyze Audit Results to Assess Conformance to Requirements
Documentation of Findings and Corrective Actions
Management Responsibility for Implementation of Corrective Actions
Verification of Corrective Actions
Chapter 15: Documents and Records Management
Documentation Hierarchy
Documents and Records
Good Documentation Practices
Master Documents
Executed Documents
GMP Records
Training Records
Facility Records
Material Receipts
Batch Records
Log Books
Complaint Records
Records Management
Record Retention
Litigation Concerns
Chapter 16: Product Quality Complaints and Adverse Event Reports
Importance of Post-Market Surveillance and Reporting
Building an Effective Complaint Management System
Adverse Event Reporting—FAERS
Differences between Compaints and Adverse Events
Keys to Compliance
Chapter 17: Product Trend Requirements
Regulations
Annual Product Reviews
General Requirements
Data Elements
Product Quality Reviews
General Requirements
Data Elements Mandated by EU Regulations
Additional Considerations
Chapter 18: Supplier and Contractor Quality Management
Requirements for Materials and Services
On-Site Audit
Quality System Survey
Change Control
Trending
Supplier Certification
Supply Chain Considerations
Registration, Evaluation, Authorization, and Restriction of Chemicals (REACh)
Restriction of Hazardous Substances (RoHS)
Conflict Minerals
Animal Tissue
Counterfeit Medicine and Medicinal Components
Part III: Laboratory Systems
Chapter 19: Compendia (US, Europe, and Japan)
Analytical Tests
Chapter 20: Laboratory Investigations of Atypical Results
Regulatory Guidance
Analytical Error
Conducting an OOS Investigation
Analytical OOS Investigations
Full-Scale OOS Investigation
Production Review
Reporting Testing Results
Concluding the Investigation
Interpretation of Investigation Results
Microbiology OOS Investigations
Standard Operating Procedures and Protocol
Identification (Speciation) of the Organism
Record of Laboratory Tests and Deviations
Monitoring of Production Area Environment
Monitoring Personnel (Laboratory and Production)
Product Bioburden
Production Record Review
Manufacturing History (Including Media Fills Where Applicable)
API Source
Excipients
Satellite Facilities
Contract Laboratories
Case Study
Objectionable Microorganisms
Absolute Number of Organisms Seen
The Characteristics of the Microorganism
Product Characteristics
Route of Administration
Patient Population
Chapter 21: Instrument Management
Chapter 22: Specifications
Development of Specifications
Criteria for Establishing Specifications
Raw Material Specifications
Drug Substances
Inactive Ingredients (Excipients)
Intermediates
Packaging Components
Finished Drug Product
Finished Product Specifications
Acceptance Limits for Excipients
Additional Considerations
Specification Revision
Chapter 23: Laboratory Record-Keeping and Data Requirements
Significant Digits and Rounding
Rules for Significant Digits/Figures
Maintaining Significant Digits in Calculations
Rounding with Significant Figures
Chapter 24: Laboratory Handling Controls
Incoming Material Receipt, Inspection, and Sampling
Samples for Products Manufactured In-House
Stability Samples
Reagents or Solutions
Calibration and Laboratory Standards
Sample Storage
Reagents or Solutions
Analytical Standards
Chapter 25: Stability Programs
Types of Stability Studies
Product Development Stability
Commercial Support Stability
Change Management Stability
Execution of Stability Studies
Conditions
Time Points
Packaging Configurations
Accelerating Studies
Chapter 26: Reserve Samples and Retains
Part IV: Infrastructure: Facilities, Utilities, Equipment
Chapter 27: Facilities
Introduction
Design and Construction Features (21 CFR 211.42)
Lighting (21 CFR 211.44)
Ventilation, Air Filtration, Air Heating and Cooling (21 CFR 211.46)
Plumbing (21 CFR 211.48)
Sewage and Refuse (21 CFR 211.50)
Washing and Toilet Facilities (21 CFR 211.52)
Sanitation (21 CFR 211.56)
Maintenance (21 CFR 211.58)
Chapter 28: Cleanrooms
Specific ISO Sections Related to Cleanrooms
ISO 14644-2:2000
ISO 14644-1:1999
ISO 14644-2:2000
ISO 14644-3:2005
ISO 14644-4:2001
ISO 14644-5:2004
ISO 14644-6:2007
ISO 14644-7:2004
ISO 14644-8:2013
ISO 14644-9:2012
ISO 14698-1:2003
ISO 14698-2:2003
Cleanroom Operation
Cleanroom Personnel
Gowning and Hygiene
Glove Donning Techniques
Sources of Contamination
Gowning Recommendations
Chapter 29: Utilities
Chapter 30: Equipment
Design
Materials of Construction
Lubricants
Equipment Layout
Equipment Cleaning Validation
GMP of Cleaning Validation and Analytical Methods
Cleaning Validation and Sampling, Rinsing, Rinse Samples, and Detergents
Establishment of Cleaning Validation Limits
Documentation
Equipment Cleaning
Maintenance
Equipment Change Control
Chapter 31: Qualification and Validation
Introduction
Validation Master Plan (VMP) and Master Validation Plan (MVP)
Design Qualification
Commissioning and Qualification
Installation Qualification
Operational Qualification
Performance Qualification
Process Validation
Validation Life Cycle
Chapter 32: Maintenance and Metrology Systems
Measurement Systems Analysis (MSA) or Test Method Validation (TMV)
Chapter 33: General Cleaning, Sanitization, and Pest Control
Washing Facilities and Cleaning Procedures
Sanitization Procedures
Literature Efficacy of Various Sanitizers
Pest Control
Chapter 34: Automated or Computerized Systems
System Life Cycle
Validation and Qualification
Regulatory References
Open and Closed Systems
Change Management
Testing Changes
Chapter 35: Societal Security—Business Continuity Management Systems
An Overview of ISO 22301:2012
The PDCA Approach
Brief Overview of Key Clauses of ISO 22301:2012 Business Continuity Standard
Clause 4: Context of the Organization
Clause 5: Leadership
Clause 6: Planning
Clause 7: Support
Clause 8: Operation
Clause 9: Performance Evaluation
Clause 10: Improvement
Part V: Materials Management and Supply Chain
Chapter 36: Receipt of Materials
Incoming Inspection
Identification and Labeling of Starting Materials
API GMP for Receipt of Materials
Chapter 37: Sampling Processes
General Sampling Requirements
Sampling Facilities, Utensils, and Equipment
Sample Containers and Labeling
Training of Personnel
Sampling of Starting Materials for API Manufacturing
Sampling of Packaging Materials
Chapter 38: Material Storage, Identification, and Rotation
Material Storage
Material Identification
Stock Rotation and Control
Control of Obsolete and Outdated Materials and Products
Chapter 39: Shipping and Distribution
Chapter 40: Traceability and Sourcing
Traceability
Raw Materials and Components
Product Manufacturing and Packaging
Finished Dosage Form
Distribution Records
Biological Agents
Pharmaceutical Supply Chain
Chapter 41: Salvaged/Returned Goods and Destruction
Returned Drug Products
Salvaged Drug Products
Disposal of Drug Products
Part VI: Sterile and Nonsterile Manufacturing Systems
Chapter 42: Master Batch and Completed Batch Records
Issuance
Yield
Critical Step Verification
Processing Instructions
Hold Times
Completed Batch Records
Review and Disposition of PBR
Chapter 43: Production Operations
General
Process Validation
Application Factors
Human Drugs
Nonsterile Manufacturing and Manufacturing of Liquids, Creams, and Ointments
Sanitization and Protection
Gowning Requirements
Sanitization and Hygiene
Chapter 44: In-Process Controls
21 CFR 211.110 and Eudralex Volume 4
21 CFR 211.110(b) Appropriate Written Procedures
21 CFR 211.110(c) In-Process Material Testing
21 CFR 211.110(d) Rejected In-Process Materials
FDA Guidance—Powder Blends and Finished Dosage Units
Time Limits
Microbiological Contamination
Contamination Control
21 CFR 211.115 Reprocessing
Combination Products
Biotechnology Products
Viral Clearance
Inactivation
Manufacturing and Aseptic Processing
Lyophilization
Chapter 45: Dispensing and Weighing Controls
Weighing Equipment
Dispensing Utensils
Staging Areas
Weigh Room
Weighing Process
Audit
Chapter 46: Requirements for Critical Unit Processes
Hazard Analysis and Critical Control Points (HACCP)
Hazard Analysis
Critical Control Point Identification
Establishment of Critical Limits
Monitoring Procedures
Corrective Actions
Record Keeping
Verification Procedures
Good Manufacturing Practices
Chapter 47: Contamination and Cross-Contamination
Introduction
Warning Letter Citations
Causes of Contamination and Cross-Contamination
Methods for Preventing Contamination and Cross-Contamination
Equipment Cleaning
Equipment-Related Parameters
Residue Removal
Cleaning Agents
Cleaning Processes
Process Variables
Proper Identification and Labeling
Line Clearance
Summary
Chapter 48: Reprocessed and Reworked Materials
Reprocessing
Reworking
Part VII: Filling, Packaging, Labeling
Chapter 49: Filling Operations and Controls
Materials Control
Filling Assembly Procedures
Filling Equipment Controls
Contamination Controls
Staged Materials
Status Labeling
Chapter 50: Environmental Monitoring
Nonviable Particle Monitoring
Contact Plates
Swab Monitoring
Settle Plates
Active (Viable) Air Monitoring
Chapter 51: In-Process and Finished Goods Inspections
Inspection Methodologies
Visual Inspection
Seal Quality Inspection (Airborne Ultrasound)
Nondestructive Leak Testing (Vacuum Decay)
Bubble Emission Testing
Blister Package Inspection and Container Leak Testing
Burst Testing
Creep Testing
Dye Penetration
Freeze-Dried Product Leak Testing
Automated Vision Inspection Systems
Qualification and Calibration
Chapter 52: Product Inspection
Manual Visual Inspection
Training
Qualification
Chapter 53: Packaging Operations and Controls
Content Protection
Types of Plastics Used for Pharmaceutical Packaging
Types of Glass Used for Pharmaceutical Packaging
Packaging Operation Controls
The Packaging Line
Chapter 54: Labeling Operations and Controls
Label Receipt
Labeling Issuance to Manufacturing
Label Quality and Label Operations
Expiration Dating
Artwork Development and Controls
Printing Process
Vendor Proof
Gang Printing
Roll Label Splicing
Off-Line Printing
Secure Storage of Labeling
Destruction of Labeling
Control of Graphical Files and Printing Plates
Examples of FDA Warning Letters
Other Examples of FDA Warning Letters
Chapter 55: Filling and Packaging Records
Regulations and Guidance Documents
Filling and Packaging Records
Production, Process Control, and Laboratory Record Review
Part VIII: Product Development and Technology Transfer
Chapter 56: Quality by Design Concepts
Quality by Design
Critical Process Parameter
Critical Quality Attributes
Design Space
Validation Principles with Quality by Design
Process Analytical Technology Tools
Multivariate Tools
Process Analytical Technology
Process Control Tools
Control Charts
Continuous Improvement and Knowledge Management Tools
Chapter 57: Phase-Appropriate GMP Requirements
Clinical Trials
Observational Studies
Participating in a Clinical Study
Informed Consent
Institutional Review Boards
Combination Products
Investigational Products
Change Control
Chapter 58: Raw Materials, Packaging, and Infrastructure for Product Development
Chapter 59: New Product Development Studies and Reports
Chapter 60: Scale-up and Transfer Activities
Development and Validation Reports
Technology Transfer Types
Process Development and Characterization Studies
Process Ranging Studies
Process Capability Studies
In-Process Control Studies
Hold-Time Studies
Physico-Mechanical Simulations and Shipping Studies
Appendix A: At-a-Glance Comparisons
Appendix B: 21 CFR 211 Pharmaceuticals GMP Overview
Appendix C: 21 CFR 820 Medical Device GMP Overview
Appendix D: Body of Knowledge—Pharmaceutical GMP Professional Certification (CPGP)
Glossary
References and Suggested Reading
Index

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