Performance qualification (PQ)

The last qualification stage: documented verification that equipment, utilities or systems perform consistently under actual or simulated production conditions, against the user requirement specification. Japanese documents use two names for this stage, this one and a longer form that adds a word for 'in operation' (稼働性能適格性評価); both mean the same thing. Do not confuse equipment PQ with process performance qualification (PPQ), which uses commercial-scale batches to confirm the manufacturing process. In the V-model, PQ closes the loop back to the user requirements.