Tab Article

List of Figures and Tables
Acronyms and Abbreviations
Preface
Acknowledgments

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 (SMF), Validation Master Plan (VMP), Drug Master File (DMF), and Site Reference File (SRF)

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 (CAPA)
Chapter 14 : Audits and Self-Inspections
Chapter 15 : Documents and Records Management
Chapter 16 : Product Quality Complaints and 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 Atypical Results
Chapter 21 : Instrument Management
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 : General 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 Nonsterile 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 : Product Inspection
Chapter 53 : Packaging Operations and Controls
Chapter 54 : Labeling Operations and Controls
Chapter 55 : Filling and Packaging Records

Part VIII : Product Development and Technology Transfer
Chapter 56 : Quality by Design Concepts
Chapter 57 : Phase-Appropriate GMP Requirements
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

Appendix A : At-a-Glance Comparions
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