Process Validation

Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes (EU GMP Annex 15). Initial validation establishes this capability; the state of control is then confirmed continuously across the lifecycle via Ongoing Process Verification. Distinct from that is Continuous Process Verification – an alternative validation approach, not a monitoring instrument; Annex 15 keeps the two apart.