Glossary
Validation Report
A document comparing validation results against the acceptance criteria and recording deviations, conclusions, and any recommendations.
Source · EU GMP Annex 15, §§2.7–2.10; MFDS, 「알기 쉬운 GMP 용어집」 Korean original
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Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Furthermore, you did not provide a sterility validation report from (b)(4) for the specific lot number of (b)(4) in question.
FDA · FDA Warning Letter · 2023-08-08 -
The process validation report, GS-2023-025 (dated 07/03/2023) cited multiple samples failing a (b)(4) in endotoxins.
FDA · FDA Warning Letter · 2025-03-11 -
In your response regarding unknown peaks for the UPLC amino acid analysis, in part you state that you have revised your cleaning procedures for laboratory glassware, however, you did not provide a cleaning validation report demonstrating the effectiveness of the new cleaning procedure.
FDA · FDA Warning Letter · 2024-05-21
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, §§2.7–2.10; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
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