Process validation does not end when the validation batches pass. Regulators expect manufacturers to keep showing that a process remains in a state of control during routine production — what the FDA’s process validation guidance calls stage 3, continued process verification, and EU GMP calls ongoing process verification. In practice, many sites still do this in spreadsheets that are hard to control and harder to defend in an inspection.
How a CPV run works
A CPV run in Swat iQua Suite is set up for one product version and one parameter — a critical process parameter or a critical quality attribute — with its lower and upper specification limits, target and review period. Your team enters the data points for the period, each tagged to the batch it belongs to. When the run is prepared, the server calculates the mean, standard deviation, Cp, Cpk, ±3σ control limits and any out-of-control points, and freezes them into a snapshot. A second person reviews and approves the run with an e-signature, and it is closed at the end of the review period.
Product and process knowledge
CPV makes most sense when everyone agrees which parameters matter and why. The product and process knowledge register holds approved CQA and CPP items for each product version: parameter, target, lower and upper limits, the rationale and the source reference. Approval is segregated and e-signed, approved items cannot be edited, and a correction is a new draft that supersedes the old item when it is approved — supporting the knowledge-management expectations of ICH Q10.
Data points are entered into the run by your team. CPV runs sit alongside the electronic batch record, QC results and the product quality review in the same platform, so the evidence is one click away.