Definition

A detailed description of the pharmacovigilance system used by an MAH, maintained at the QPPV location and available for inspection.

Example

The PSMF describes: organizational structure, QPPV responsibilities, database details, process flows for case handling, signal management, and contractual arrangements with service providers.

Regulatory source

EU GVP Module II

Common mistakes

Not keeping the PSMF current as processes, personnel, or systems change.

Inspector question

Show me your PSMF. When was it last updated? How do you ensure it reflects current operations?

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