Definition

Adherence to Good Pharmacovigilance Practice as defined in EU guidance modules covering all aspects of pharmacovigilance operations.

Example

GVP compliance requires: qualified personnel, documented procedures, validated systems, timely reporting, signal management, RMP maintenance, and auditable records.

Regulatory source

EU GVP Modules I-XVI

Common mistakes

Treating GVP as a checklist rather than a comprehensive quality framework.

Inspector question

How do you assess and ensure ongoing GVP compliance across your organization?

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