Definition

Document describing the MAH's PV system (structure, processes, resources). Required in EU and must be kept up to date and available for inspection.

Example

PSMF includes QPPV, database, SOP list, outsourcing, and signal process.

Regulatory source

GVP Module I

Common mistakes

PSMF outdated or not aligned with actual processes.

Inspector question

When was your PSMF last updated and where is it stored?

Related terms