Standard Operating Procedures, Templates and Manuals

Part 1: Standard Operating Procedures

1.1: GMP Quality Assurance and Compliance Procedures

1.1.1: Quality Assurance Templates

1.2: Pharmaceutical Audit Training Manuals

1.3: Process/Cleaning/Method/Computer Validation Procedures

1.3.1: Validation Templates

1.4: Quality Control Analytical Laboratory Procedures

1.5: Microbiology Laboratory & Sterility Testing Procedures

1.6: Standard Operating Procedure for Packaging Operation

1.7: Warehouse Management Procedures

1.8: Environmental Health and Safety Procedures

Part 2: Quality and Validation Manuals

Part 3: Quality and Validation Guidance

3.1: Analytical Test Method Validation Guidance

3.2: Cleaning Validation Guidance

3.3: Process Validation, Packaging and Equipment Qualification Guidance

3.4: Quality Management Guidance

3.5: Aseptic Operations Guidance

Part 4: GMP Good Practices

Good Practice 01: Good Working Practice on Facilities and Equipment

Good Practice 02: Good Working Practice on Material Management

Good Practice 03: Good Working Practice on Labelling and Packaging

Good Practice 04: Good Working Practice on Manufacturing Operations

Good Practice 5: Good Practice on Laboratory Management

Good Practice 6: Good Practice on Validation Requirements

Part 5: List of All Quality Forms

Part 6: GMP Skill Booster Modules and Quiz