Continued process verification (CPV)

Ongoing collection and evaluation of process and product data during commercial manufacturing to confirm that the process stays in a state of control. Two English terms share the abbreviation. FDA's continued process verification is Stage 3 of its process validation lifecycle and follows PPQ. ICH Q8 and EU guidance describe continuous process verification, an alternative to traditional process validation based on continuous monitoring of manufacturing performance. The Japanese term can stand for either. When a Japanese document or CDMO proposal mentions CPV, ask which concept is meant and whether it follows validation batches or replaces them.