Process performance qualification (PPQ)

The stage of process validation in which the commercial process, run at commercial scale with qualified equipment and trained staff under the established control strategy, is shown to produce product of the intended quality reproducibly. The term comes from FDA's 2011 process validation guidance, where PPQ is part of Stage 2; EU and PIC/S texts speak of process validation batches. PPQ batches are made before commercial launch. Japanese documents use the English abbreviation with the Japanese name. Agree the number of batches, sampling plan and statistical acceptance criteria with the client early, because they drive both cost and timeline.