Glossary
Preventive Action
Action to eliminate the cause of a potential nonconformity or other undesirable situation so that it does not occur.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Preventive Action; ICH Q10 §3.2.2 Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your investigations into out-of-specification (OOS) laboratory results are inadequate because they do not include scientifically supported conclusions and lack corrective actions and preventive actions (CAPA).
FDA · FDA Warning Letter · 2022-08-30 -
You failed to conduct adequate investigations and to implement effective corrective actions and preventive actions (CAPA) to prevent recurrence of vial breakage during manufacturing of sterile injectable drug products.
FDA · FDA Warning Letter · 2024-08-20 -
We also recommend that the qualified third party perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the effectiveness of your corrective actions and preventive actions.
FDA · FDA Warning Letter · 2021-03-22
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
MFDS, 「알기 쉬운 GMP 용어집」, Preventive Action; ICH Q10 §3.2.2 Korean originalGRM Regulatory Glossary
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