Facility Inspection
Part 1 - GMP Standard Operating Procedures
1.1 - Validation Procedures SOPs
1.1.1 - Process/Cleaning/Method Validation Procedures
1.1.2 - Computer System Validation Procedures
1.1.3 - Validation Templates
1.2 - Quality Assurance and Compliance Procedures SOPs
1.2.3 - Quality Assurance Templates
1.3 - Quality Control Laboratory Procedures SOPs
1.4 - Microbiology (Sterile) Laboratory Procedures SOPs
1.5 - Standard Operating Procedure for Packaging Operation
1.6 - Warehouse Management Procedures SOPs
1.7 - Environmental Health and Safety Procedures SOPs
Part 2 - GMP Auditor Training Manuals
Part 3 - GMP Manuals
3.1 - Quality Manuals
3.2 - Validation Manuals
3.3 - Laboratory Manuals
3.4 - Operation Manuals
Part 4 - Good Working Practice
Practice 4.1: Good Practice on Facilities and Equipments
Practice 4.2: Good Practice on Material Management
Practice 4.3: Good Practice on Labelling and Packaging
Practice 4.4: Good Practice on Manufacturing Operations
Practice 4.5: Good Practice on Laboratory Management
Practice 4.6: Good Practice on Validation Requirements
Practice 4.7: Good Practice on Quality Management Systems
Part 5 - GMP Guidance
5.1 - Validation Guidance
5.1.1 - Method Validation
5.1.2 - Cleaning Validation
5.1.3 - Other Validation
5.2 - Quality Management Guidance
5.3 - Aseptic Processing Area Guidance