PPQ
Process Performance Qualification · process performance qualification · stage 2
The validation stage that proves the commercial manufacturing process consistently produces in-spec product — usually three consecutive successful batches.
Process Performance Qualification (PPQ) is Stage 2 of FDA's 2011 Process Validation lifecycle. It is the formal demonstration that the commercial-scale process, under routine conditions and with trained operators, reliably produces product meeting all CQAs. The historical 'three validation batches' rule is the most common interpretation but FDA expects a science- and risk-based justification of the batch count.
PPQ relies on extensive sampling, in-process monitoring and a pre-approved PPQ protocol. V5 supports PPQ by capturing every kiosk weighing, in-process QC, equipment ID, environmental reading and operator signature into the immutable batch record, then exposes the data as ready-to-cite evidence for the PPQ report.
- FDA Process Validation 2011
- 21 CFR 211.100
- EU GMP Annex 15