Definition

An assessment of third-party service providers performing pharmacovigilance activities to verify capability, compliance, and quality.

Example

Pre-contract vendor audit of a CRO examines: PV qualifications, training records, system validation, SOPs, capacity, and previous inspection history.

Regulatory source

EU GVP Module I, ICH Q10

Common mistakes

Conducting superficial vendor audits that don't adequately assess PV-specific competencies.

Inspector question

How do you qualify and audit PV service providers? What criteria must they meet?

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