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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.
Pam Bones and members of the RQA Good Pharmacovigilance Practice Working Party
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Comparison of Pharmacovigilance Regulations in Europe and Japan*
Management of the Training and Competency of Personnel in GxP and Research Environments
Pharmacovigilance Agreements (PVAs): Guidance on the Quality Oversight and Operational Aspects*
P11 A Systems Approach to Good Pharmacovigilance Practice
P35 Practical Pharmacovigilance Auditing
P36 Practical Approach to Good Pharmacovigilance Regulatory Inspections
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting
RP35 Practical Pharmacovigilance Auditing REMOTE LEARNING