CPV Plan
Continued Process Verification Plan · continued process verification plan · stage 3 validation plan
The Stage 3 process-validation document defining what data is collected, how it is trended, and how signals trigger investigation across a product's commercial lifetime.
A CPV Plan is the Stage 3 deliverable of FDA's process-validation lifecycle (and ICH Q8–Q12). It specifies the Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and in-process attributes that must be trended commercially, the statistical rules used to detect drift, and the escalation path when a signal fires.
V5 runs the CPV plan as live SPC against every batch: trend rule breaches automatically create deviations and feed the Annual Product Review.
- FDA Process Validation Guidance (2011)
- ICH Q10
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