Definition

An official examination by a regulatory authority of a company's pharmacovigilance system, processes, and documentation to verify compliance with regulations.

Example

EMA conducts a routine pharmacovigilance inspection at the QPPV site, reviewing the PSMF, case processing records, signal management documentation, and PSUR procedures.

Regulatory source

EU GVP Module III, 21 CFR 312/314

Common mistakes

Treating inspections as adversarial events rather than opportunities to demonstrate a robust PV system.

Inspector question

Describe your previous inspection history. What findings were identified and how were they resolved?

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