GMP

• 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 

• The Certified Pharmaceutical GMP Professional Handbook
• Good Manufacturing Practices (GMP) for Pharmaceuticals (2020)