Continued Process Verification (CPV) Plan
Stage 3 CPV plan template per the FDA Process Validation Guidance (2011) lifecycle: the CQAs and CPPs monitored, sampling plan and frequency, statistical control approach and signal rules, review cadence and roles, out-of-trend response, and linkage to periodic product review.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A Stage 3 plan under the FDA Process Validation Guidance (2011) lifecycle: an ongoing programme providing continual assurance that the process remains in a state of control during routine commercial manufacture — defining what is monitored, how it is analysed statistically, who reviews it, and what happens when a signal appears.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
The FDA Process Validation Guidance (2011) defines Stage 3 — continued process verification — as ongoing assurance that the process remains in a state of control, and 21 CFR Part 211 requires review of production data. ICH Q10 supplies the process performance and product quality monitoring system this plan operationalises, with CQA/CPP framing from ICH Q8(R2).
WHERE NEXT
- FILL IT INHow to Establish Continued Process Verification →The procedure this template records, one step at a time.
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