Pharmaceutical companies typically manufacture at laboratory bench and pilot-scale for preliminary preclinical and toxicology studies and on occasion for phase I clinical trials. As more product is required to support phase II and phase III clinical studies, the manufacturing operations need to be scaled-up and prepared for process validation.
A key part of the process development activities is the early identification of critical process steps to significantly help the design and delivery of process validation. Inadequate or poorly defined process development and identification of critical process steps can seriously impact the long-term product viability when product lifecycle changes can be commercially inhibitory.
Process development and validation should be documented in a systematic fashion to accurately document the changes made to the process. Documents needed to track the process include:
- Process development reports
- Technical reports
- Validation master plan
- Validation protocols including IQ, OQ, and PQ