Definition

A systematic, independent examination of pharmacovigilance activities conducted by the company's quality function to ensure compliance and identify improvement opportunities.

Example

Annual internal audit of expedited reporting examines: timeliness metrics, case selection, data quality, and regulatory compliance across a sample of cases.

Regulatory source

ICH Q10, EU GVP Module I

Common mistakes

Auditing to show compliance rather than genuinely assessing process effectiveness and identifying risks.

Inspector question

Show me your internal audit schedule. How do you select audit topics and scope?

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