Ongoing Process Verification (OPV)
Ongoing Process Verification
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
EU GMP Annex 15’s term for Stage 3 of the process validation lifecycle — the continued collection and evaluation of process and product data during routine commercial manufacture to confirm the process remains in a state of control — functionally aligned with FDA’s Continued Process Verification.
OPV and CPV describe the same underlying idea from two regulatory frameworks: validation does not end once Process Performance Qualification runs are complete. Routine batches continue to generate process and quality data, and that data is actively trended — not merely archived — to confirm the process stays inside the state of control demonstrated during PPQ.
The scope, parameters trended, and review frequency for OPV are defined in the site’s validation or monitoring plan, and the trended output feeds directly into the site’s annual product quality review. A sustained or worsening trend can prompt an investigation and, where warranted, a requalification or revalidation of the affected process.
- —EU GMP Annex 15 terminology for Stage 3 of the process validation lifecycle
- —Functionally equivalent in intent to FDA’s Continued Process Verification (CPV)
- —Data is actively trended, not just collected and filed
- —Feeds directly into the site’s Annual Product Quality Review
- —A sustained adverse trend can trigger investigation and requalification
EU GMP Annex 15; FDA Process Validation: General Principles and Practices (2011)
Frequently asked questions
What does Ongoing Process Verification (OPV) stand for?
Ongoing Process Verification (OPV) stands for Ongoing Process Verification.
What is Ongoing Process Verification (OPV)?
EU GMP Annex 15’s term for Stage 3 of the process validation lifecycle — the continued collection and evaluation of process and product data during routine commercial manufacture to confirm the process remains in a state of control — functionally aligned with FDA’s Continued Process Verification.
Which regulations cover Ongoing Process Verification (OPV)?
EU GMP Annex 15; FDA Process Validation: General Principles and Practices (2011)