FDA AND GLOBAL REGULATORY INSPECTION EXPECTATIONS FOR CPV
FDA and Global Regulatory Inspection Expectations for CPV Regulatory authorities expect Continued Process Verification (CPV) to be an integral part of the Pharmaceutical Quality System (PQS). During inspections, investigators typically evaluate whether manufacturers have established a scientifically justified and risk-based program to continuously monitor commercial manufacturing processes. Inspectors commonly review: Documented CPV procedures and responsibilities … Read more