- Global Regulatory Framework
- Regulations and Guidances
- Mutual Recognition Agreements
- Regulatory Inspections
- Enforcement Actions
- Regulatory Agency Reporting
- Site Master File and Drug Master File
- Quality Management System
- Quality Unit (Site) Management
- Risk Management
- Training and Personnel Qualifications
- Change Control and Management
- Investigations and Corrective and Preventive Action
- Audits and Self-Inspections
- Documents and Records Management
- Product Quality Complaints versus Adverse Event Reports
- Product Trend Requirements
- Supplier and Contractor Quality Management
- Compendia (US, Europe, and Japan)
- Laboratory Investigations of Aberrant Results
- Instrument Control and Record Keeping Specifications
- Laboratory Record-Keeping and Data Requirements
- Laboratory Handling Controls
- Stability Programs
- Reserve Samples and Retains
- Facilities
- Cleanrooms
- Utilities
- Equipment
- Qualification and Validation
- Maintenance and Metrology Systems
- Cleaning, Sanitization, and Pest Control
- Automated or Computerized Systems
- Societal Security—Business Continuity Management Systems
- Receipt of Materials
- Sampling Processes
- Material Storage, Identification, and Rotation
- Shipping and Distribution
- Traceability and Sourcing
- Salvaged/Returned Goods and Destruction
- Master Batch and Completed Batch Records
- Production Operations
- In-Process Controls
- Dispensing and Weighing Controls
- Requirements for Critical Unit Processes
- Contamination and Cross-Contamination
- Reprocessed and Reworked Materials
- Filling Operations and Controls
- Environmental Monitoring
- In-Process and Finished Goods Inspections
- Parenteral Product Inspection
- Packaging Operations and Controls
- Labeling Operations and Controls
- Filling and Packaging Records
- Artwork Development and Controls
- Quality by Design Concepts
- Phase-Appropriate GMP Requirements
- Raw Materials, Packaging, and Infrastructure for Product Development
- New Product Development Studies and Reports
- Scale-up and Transfer Activities
GMP Book
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