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