CPV
Continued Process Verification · stage 3 validation · ongoing process verification · opv
The ongoing-monitoring stage of process validation — SPC on CQAs/CPPs across every commercial batch, forever.
Continued Process Verification (CPV) is Stage 3 of FDA's Process Validation guidance — the lifelong on-going statistical monitoring of Critical Quality Attributes and Critical Process Parameters across every commercial batch. EU GMP §1.10(b) imposes a parallel expectation called Ongoing Process Verification.
Without CPV, your validation lifecycle is dead the day PPQ ends. CPV requires live SPC, owner-assigned alerts, periodic CPV reports (typically annual) and links from drift to CAPA. V5 builds CPV automatically: every batch closure feeds the SPC engine, control limits are owner-tuned per parameter, and the annual CPV report assembles from live data.
- FDA Process Validation 2011 Stage 3
- EU GMP §1.10(b)