Definition

A systematic approach to investigating the root cause of quality issues and implementing actions to correct and prevent recurrence.

Example

Multiple late submissions are identified. CAPA investigation reveals inadequate triage training. Corrective action: re-train staff. Preventive action: implement automated alerts for approaching deadlines.

Regulatory source

ICH Q10, 21 CFR 820.100

Common mistakes

Addressing only the immediate correction without investigating root cause or implementing preventive measures.

Inspector question

Show me a recent CAPA from your pharmacovigilance operations. How did you verify effectiveness of the actions taken?

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