Glossary
Validation
Demonstrating and documenting that a procedure, process, equipment, material, activity, or system actually gives the expected result.
Source · EU GMP Annex 15, §12 Glossary, Validation
Details
Validation is a lifecycle activity that establishes documented, high level assurance that a process, procedure, or system consistently produces the intended result. Inspections cite criteria altered to fit the results because none were approved in advance, and operation continued with deviations or changes left unclosed. Check the validation master plan, risk assessments, protocols, raw data, and reports, requirements traceability, and the basis for changes and revalidation.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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product lines, you have not conducted cleaning validation studies.
FDA · FDA Warning Letter · 2021-03-16 -
Your firm lacks process validation studies to demonstrate reproducibility and control of your manufacturing…
FDA · FDA Warning Letter · 2026-06-09 -
Specifically, your process validation lacks an evaluation of inter-batch and intra-batch variability for (b)(4) gel (b)(4)…
FDA · FDA Warning Letter · 2022-12-06
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EU GMP Annex 15, §12 Glossary, ValidationGRM Regulatory Glossary
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