The Certified Pharmaceutical GMP Professional Handbook

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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