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Pharmacovigilance Auditing

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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 audits to consider
  4. Scope of a pharmacovigilance (PV) audit
  5. Planning and conduct of audits
  6. Topics for review
    6.1  Qualified person for pharmacovigilance (QPPV)
    6.2  Medical information/call centres
    6.3  Case processing
    6.4  Literature review
    6.5  Reference safety information (RSI)
    6.6  Aggregate/periodic reports
    6.7  Product Quality Complaints (PQCs) associated with AE
    6.8  Signal detection/signal management
    6.9  Risk management/minimisation and pharmacovigilance planning
    6.10 Interventional clinical studies
    6.11 Commercial activities
    6.12 ICSR regulatory reporting (paper/E2B)
    6.13 Quality management system (QMS) audits
    6.14 Pharmacovigilance computer systems
    6.15 Auditing safety data exchange agreements
    6.16 External service providers (CROs/vendors)


Pam Bones and members of the RQA Good Pharmacovigilance Practice Working Party




February 2017

Discount Information

Discounts are available for bulk orders. Please enter one of the following discount codes:

  • BOOK10 for orders of 10 - 19 copies - 25% discount
  • BOOK20 for orders of 20 - 49 copies - 33% discount
  • BOOK50 for orders over 50 copies - 50% discount

This discount is available for both a block of one title or a combination of titles in hardback.

If ordering 50 or more books for delivery to outside the UK, please contact the RQA office as we will need to calculate the delivery cost for you.

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