IV.B.1. Pharmacovigilance audit and its objective

Pharmacovigilance audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.

In general, an audit is a systematic, disciplined, independent and documented process for obtaining evidence and evaluating the evidence objectively to determine the extent to which the audit criteria are fulfilled, contributing to the improvement of risk management, control and governance processes (3).

Audit evidence consists of records, statements or other information, which are relevant to the audit criteria and verifiable. Audit criteria are, for each audit objective, the standards of performance and control against which the auditee and its activities will be assessed. In the context of pharmacovigilance, audit criteria should reflect the requirements for the pharmacovigilance system, including its quality system for pharmacovigilance activities, as found in the legislation and guidance.