The Certified Pharmaceutical GMP Professional Handbook
The purpose of this handbook is to highlight and partially annotate what the founders of the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination believed to be the main topics comprising worldwide pharmaceutical good manufacturing practices (GMP). Logic and deduction aided the examination development volunteers and the professional staff of the Certification Offerings group at ASQ during their drafting and finalization of the inaugural version of the CPGP body of knowledge (BoK). The latter undergoes review and revision every five years per certification offerings and ASQ policy and procedures. Because each ASQ examination handbook must reflect the current BoK of its exam, this handbook will obligatorily undergo revision processes after all future CPGP BoK revisions. As the world becomes ever more paperless and electronically nimble and adaptive to changes, reference books such as the CPGP Handbook are obligated to provide as many means as possible of bridging, if not transcending, the predictable (and inevitable) changes to laws, regulations, guidelines/guidance documents, compendia, and consensus standards. This handbook inculcates the reader in where and how to tap appropriate URLs and other sources of the changing laws, regulations, guidelines, compendia, and consensus standards.
Part I: Regulatory Agency Governance
Chapter 1 Global Regulatory Framework
Chapter 2 Regulations and Guidances
Chapter 3 Mutual Recognition Agreements
Chapter 4 Regulatory Inspections
Chapter 5 Enforcement Actions
Chapter 6 Regulatory Agency Reporting
Chapter 7 Site Master File and Drug Master File
Part II: Quality Systems
Chapter 8 Quality Management System
Chapter 9 Quality Unit (Site) Management
Chapter 10 Risk Management
Chapter 11 Training and Personnel Qualifications
Chapter 12 Change Control and Management
Chapter 13 Investigations and Corrective and Preventive Action
Chapter 14 Audits and Self-Inspections
Chapter 15 Documents and Records Management
Chapter 16 Product Quality Complaints versus Adverse Event Reports
Chapter 17 Product Trend Requirements
Chapter 18 Supplier and Contractor Quality Management
Part III: Laboratory Systems
Chapter 19 Compendia (US, Europe, and Japan)
Chapter 20 Laboratory Investigations of Aberrant Results
Chapter 21 Instrument Control and Record Keeping
Chapter 22 Specifications
Chapter 23 Laboratory Record-Keeping and Data Requirements
Chapter 24 Laboratory Handling Controls
Chapter 25 Stability Programs
Chapter 26 Reserve Samples and Retains
Part IV: Infrastructure: Facilities, Utilities, Equipment
Chapter 27 Facilities
Chapter 28 Cleanrooms
Chapter 29 Utilities
Chapter 30 Equipment
Chapter 31 Qualification and Validation
Chapter 32 Maintenance and Metrology Systems
Chapter 33 Cleaning, Sanitization, and Pest Control
Chapter 34 Automated or Computerized Systems
Chapter 35 Societal Security—Business Continuity Management Systems
Part V: Materials Management and Supply Chain
Chapter 36 Receipt of Materials
Chapter 37 Sampling Processes
Chapter 38 Material Storage, Identification, and Rotation
Chapter 39 Shipping and Distribution
Chapter 40 Traceability and Sourcing
Chapter 41 Salvaged/Returned Goods and Destruction
Part VI:Sterile and Non-sterile Manufacturing Systems
Chapter 42 Master Batch and Completed Batch Records
Chapter 43 Production Operations
Chapter 44 In-Process Controls
Chapter 45 Dispensing and Weighing Controls
Chapter 46 Requirements for Critical Unit Processes
Chapter 47 Contamination and Cross-Contamination
Chapter 48 Reprocessed and Reworked Materials
Part VII: Filling, Packaging, Labeling
Chapter 49 Filling Operations and Controls
Chapter 50 Environmental Monitoring
Chapter 51 In-Process and Finished Goods Inspections
Chapter 52 Parenteral Product Inspection
Chapter 53 Packaging Operations and Controls
Chapter 54 Labeling Operations and Controls
Chapter 55 Filling and Packaging Records
Chapter 56 Artwork Development and Controls
Part VIII: Product Development and Technology Transfer
Chapter 57 Quality by Design Concepts
Chapter 58 Phase-Appropriate GMP Requirements
Chapter 59 Raw Materials, Packaging, and Infrastructure for Product Development
Chapter 60 New Product Development Studies and Reports
Chapter 61 Scale-up and Transfer Activities
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