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Quality

Continued process verification (Stage 3)

TL;DR

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, ha...

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 engineered into every action, not bolted on.
Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
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/PQ 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
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