Covers Process Qualification and Process Performance Qualification (PPQ), demonstrating that the commercial manufacturing process can operate reproducibly under defined conditions. Topics include PPQ readiness and strategy, batch selection, sampling and data collection, CPP and control-strategy verification, acceptance criteria, statistical evaluation, deviations, investigations, and validation conclusions.
Process Performance Qualification (PPQ) is the commercial-scale demonstration that the manufacturing process defined during Stage 1 can perform reproducibly under the conditions intended for routine production. PPQ is not simply the manufacture of a predetermined number of successful batches. It…
A Process Performance Qualification (PPQ) sampling plan defines how evidence will be collected to determine whether the commercial manufacturing process performs reproducibly and whether relevant process variability is adequately understood and controlled. Sampling during PPQ should not be designed by…
Process Performance Qualification (PPQ) should verify more than whether Critical Process Parameters (CPPs) remained inside predefined limits. The more important Stage 2 question is whether the integrated process control strategy developed during Stage 1 actually works under commercial manufacturing conditions….
Process Performance Qualification (PPQ) acceptance should be based on predefined criteria and a scientifically planned evaluation of the complete dataset, not simply on whether several commercial batches were manufactured without obvious failure. Acceptance criteria establish what evidence is required before…
Process Performance Qualification (PPQ) is intended to demonstrate that the commercial manufacturing process operates reproducibly under the conditions defined during Stage 1 and implemented during Stage 2. Deviations, atypical observations, Out-of-Specification (OOS) results, and other unexpected events therefore cannot be…