Glossary
Corrective and Preventive Action (CAPA)
A system for investigating causes and implementing and verifying actions so that problems that occurred do not recur and potential problems do not arise.
Source · ICH Q10, §3.2.2 Corrective Action and Preventive Action System
Details
CAPA is a closed loop procedure that removes the cause of a confirmed nonconformity, prevents potential problems, and goes on to verify that the action taken actually worked. Inspections cite repeated retraining unrelated to the root cause, extended due dates, a narrowed impact assessment, and closure without effectiveness checks. Trace the investigation report, the evidence for the root cause, the action plan with owner and due date, change control, and the effectiveness verification record.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, you failed to identify a root cause and implement adequate CAPA.
FDA · FDA Warning Letter · 2025-11-18 -
Your response related to your disinfectant efficacy study referenced an existing CAPA for cleaning validation (CV) requirements and you also noted that an updated study was initiated.
FDA · FDA Warning Letter · 2025-11-25 -
You failed to adequately validate your manufacturing processes for all your OTC drug products and provide assurance that you are capable of consistently manufacturing a drug product with defined quality attributes…
FDA · FDA Warning Letter · 2025-04-29
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q10, §3.2.2 Corrective Action and Preventive Action SystemGRM Regulatory Glossary
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