1. Utility Qualification and Commissioning
- Water Systems
- HVAC
- Gases
- Emergency Power
2. Process Equipment Qualification
- Packaging
- Compounding Equipment
- Aseptic Process Equipment (e.g., Lyophilizers, Autoclaves)
- Filling
3. Process Validation
- Aseptic Process
- Biotech
- Solid Dose
- Liquid, Creams, Ointments
4. Computer System Qualification
- Part 11 Assessment
5. Cleaning Validation
6. Laboratory Equipment Qualification