Annex 15 — qualification and validation

Annex 15 is the reference text for how validation is organised. It defines the documentation expected — validation master plan, protocols with predetermined acceptance criteria, and reports concluding against those criteria — and it sets out the qualification sequence from user requirements through design, installation, operational and performance qualification.

For process validation it recognises three approaches: traditional, continuous process verification and a hybrid. It is explicit that the number of batches should be justified rather than assumed, which is the point most often overlooked by sites defaulting to three without a rationale.

Two areas people forget are inside its scope. Transport verification asks you to demonstrate that products are not adversely affected by transport conditions, which for temperature-sensitive product is a real study rather than an assumption. Packaging validation covers primary packing equipment operating ranges — a common source of defects that surface as complaints rather than as manufacturing deviations.

The annex also closes the loop back to change control by setting expectations for requalification and revalidation. Validation is a maintained state; changes are what threaten it; change control is where the assessment happens. A site with strong validation documents and weak change control will not stay validated for long.