Process Validation

Documented evidence that a manufacturing process, operated within defined parameters, consistently produces product meeting its specification.

Three stages, not three batches

Stage 1 is process design, stage 2 is process qualification (the PPQ batches), and stage 3 is continued process verification across commercial production. Treating validation as 'three batches and done' is the most common finding in an audit.

What gets fixed first

Critical process parameters and critical quality attributes are defined before PPQ, with the acceptance criteria written into the protocol — not selected after the results are in.

Related terms

Technology Transfer
Engineering Batch

Where this applies

General Injectables

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