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Pharmacovigilance Auditing


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Pharmacovigilance (PV) audit may be defined as a critical review and analysis of the compliance (with global and local legislation, internal Standard Operating Procedures (SOPs), contracts/agreements) of the systems supporting the monitoring of adverse events and detection signals. Its purpose is to provide assurance that the internal PV (and related) systems are robust, in order to assure the protection of public health.

The purpose of this booklet is to provide guidance to auditors to enable them to conduct effective audits of the PV system. In 2012, PV audit became a legal requirement in the EU, according to Directive 2010/84/EU. The intention of this publication is to capture the primary areas for review, to assist industry personnel with implementation of this regulatory requirement. However, this booklet may not be all inclusive and there may be additional processes or functional groups that could be included within the scope of an audit. The booklet is considered to be fairly comprehensive, capturing activities managed by central functions and those that may be managed by an affiliate company. It is envisaged that an auditor may select areas from this booklet of relevance to the system that they wish to audit.

While the focus of this booklet is the EU legislative requirements, the reality with regards to PV is that multinational companies operate in a global environment. Therefore, while national regulation must of course be considered both within the EU and ex-EU, it is anticipated that this guide may be applied as a basis for PV audit across geographical boundaries.

For those new to PV auditing, the content of this publication may appear a little overwhelming at first. We hope that it will provide some guidance as to where to start, what to include and where key areas of focus could be.


  1. Introduction
  2. Background
  3. Types of audit to consider
  4. Scope od a pharmacovigilance (PV) audit
  5. Planning and conduct of audits
  6. Topics for review


Pam Bones -Team Lead, Mark Parker (Mundipharma), Lindsay Watt (GSK), Nazrul Khan (ZigZag), Louise Alford (PAREXEL International) Calvin Johnson (AbbVie) and Sandra Dunlavy (Astellas).



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November 2013

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