Continued Process Verification (CPV), Stage 3 of the FDA 2011 Process Validation Guidance lifecycle, is the ongoing statistical monitoring of CPPs and CQAs after the three PPQ batches. For supplements it typically means SPC charts on blend uniformity, capsule/tablet weight, hardness, disintegration and assay across at least the first 20–30 commercial lots, with documented triggers for re-validation when capability indices (Cpk) drift below the action limit.

Regulatory anchors

FDA Process Validation Guidance (2011)
21 CFR 111.103

How V5 handles it

QMS — quality records next to the work they concern.

Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Related terms

Process validation

Continued process verification (Stage 3)

Next step

Continued process verification (Stage 3)

Next step