Process Validation (PV, PQ)—
- Identify Critical Parameters;
- Establish realistic operational ranges;
- Strategically implement during clinical development.
Cleaning Validation and Sterilizing Validation—
- CIP and SIP optimization;
- Autoclave;
- TOC based approach;
- Multiproduct changeover cleaning strategy
Viral Clearance Validation—
Equipment Qualification (IQ, OQ, IOQ)—