Continued process verification (CPV) is the third stage of the process validation lifecycle described in the FDA’s 2011 process validation guidance: stage 1 is process design, stage 2 is process qualification, and stage 3 is continued process verification during routine commercial production. EU GMP Annex 15 describes the equivalent activity as ongoing process verification.
In CPV, a manufacturer collects data on critical process parameters and critical quality attributes from batches and analyses it statistically to show the process remains in control. Typical tools are control charts with ±3σ limits, rules for out-of-control points and trends, and process capability indices such as Cp and Cpk, which compare the spread of the process with its specification limits.
Why it matters in GMP
Validation is not a one-off event. Raw material variability, equipment wear and small process changes can shift a process over time. CPV detects that drift before it produces an out-of-specification batch, and its conclusions feed the annual product quality review and continual improvement under ICH Q10.
- Select the parameters and attributes that matter, based on product knowledge and risk.
- Define statistical methods and alert rules in an approved plan.
- Review results periodically and act on adverse trends.
How Swat iQua Suite handles it
Swat iQua Suite runs CPV reviews per product version and parameter, with lower and upper specification limits, a target and a review period. You enter the data points, optionally tagged to a batch, and on preparation the server calculates the mean, standard deviation, Cp, Cpk, ±3σ control limits and out-of-control points into a snapshot that cannot be changed. Approval is e-signed by someone other than the preparer, and approved CQA and CPP knowledge items provide context.