Glossary
Revalidation
Reconfirming, following a change or the outcome of a periodic review, that a process, equipment, or system remains in a validated state.
Source · WHO TRS 1019 Annex 3, GMP guidelines on validation; MFDS, 「알기 쉬운 GMP 용어집」 Korean original
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Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You fail to provide sufficient details on the proposed cleaning revalidation and product impact assessment.
FDA · FDA Warning Letter · 2026-09-29 -
Modifying the potency test method to obtain passing potency results without scientific justification and revalidation, and without assessing the impact of these changes on the accuracy of the potency results for all previously distributed batches within expiry; b.
FDA · FDA Warning Letter · 2024-10-22 -
Failure to sign and date equipment validation/revalidation records.
FDA · FDA 483 · 2024-01-17
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; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
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