Explain the three FDA process validation lifecycle stages and identify evidence expected in each stage.
A team believes three successful PPQ lots permanently validate a tablet process despite upcoming supplier and seasonal variability. FDA lifecycle validation: Stage 1 process design, Stage 2 process qualification, Stage 3 continued process verification The common trap is treating PPQ as the finish line. PPQ confirms the process under defined conditions, but it does not remove the need to monitor variation, supplier changes, equipment wear, or shifts in process capability during routine production. Stage 1 Document product and process understanding: CQAs, CPPs, material attributes, prior development studies, control strategy, and known sources of variability. This stage explains why the process…
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