Glossary
Process Validation
Demonstrating that a process, within set parameters, can effectively and reproducibly produce product meeting its specification and quality attributes.
Source · WHO TRS 1019 Annex 3, GMP guidelines on validation, Glossary, Process validation
Details
Process validation demonstrates, from process design through continued verification, that the commercial process reproducibly achieves the predetermined quality attributes. Inspections cite batches that are not representative, worst case conditions and process variability not evaluated, and no trend monitoring after PPQ. Look at process design knowledge, the PPQ protocol and batch data, statistical trends, deviations and changes, and the continued process verification report.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm lacked an adequate process validation program and sufficient validation studies for your drug product…
FDA · FDA Warning Letter · 2023-09-05 -
Lack of Process Validation You failed to provide data to demonstrate that you adequately validate your manufacturing…
FDA · FDA Warning Letter · 2023-08-01 -
You lacked process validation data to demonstrate you have adequately validated your manufacturing processes used to manufacture your OTC drug products and to demonstrate your processes are reproducible and…
FDA · FDA Warning Letter · 2025-10-07
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO TRS 1019 Annex 3, GMP guidelines on validation, Glossary, Process validationGRM Regulatory Glossary
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