Pharmacovigilance Auditing eBooklet

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This second revision of the Pharmacovigilance Auditing booklet is intended to support auditors in the effective conduct of audits of the PV system by providing guidance in:
ʶ Directing audit focus to the higher risk areas of PV systems and discrete PV sub-systems to assist auditors with planning risk-based audits
ʶ The types of documentation which may be relevant for review
ʶ Additional hints and tips, and points for consideration, to help ensure audits are efficient and effective.

The booklet is considered fairly comprehensive, capturing activities managed by central functions and those that may be managed by an affiliate company. However, it is acknowledged that it is not all inclusive, and there may be additional processes or functional groups that could be included within the scope of an audit. It is envisaged that an auditor may select areas from this booklet of relevance to the system 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 it will provide some guidance as to where to start, what to include and where key areas of focus could be. Good luck!

Contents

1. Introduction
2. Background
3. Types of audits to consider
4. Scope of a (PV) audit
5. Planning and conduct of audits
6. Topics for review
   6.1 Quality Management System (QMS)
   6.2 Pharmacovigilance Computer Systems
   6.3 Pharmacovigilance System Master File (PSMF)
   6.4 Qualified Person for Pharmacovigilance (QPPV)
   6.5 Case Processing
   6.6 Individual Case Safety Report (ICSR) Regulatory Reporting (paper/E2B)
   6.7 Literature Review
   6.8 Medical Information/Call Centre
   6.9 Product Quality Complaints (PQCs) Associated with Adverse Events (AEs)
   6.10 Aggregate/Periodic Reports
   6.11 Signal Detection/Signal Management
   6.12 Risk Management/Minimisation and Pharmacovigilance Planning
   6.13 Post Authorisation Safety Studies (PASS)
   6.14 Reference Safety Information (RSI)
   6.15 Direct Healthcare Professional Communications
   6.16 Commercial Activities
   6.17 Contractual Relationships with Business Partners: Pharmacovigilance/Safety Data Exchange Agreements (SDEAs)
   6.18 External Service Providers (CROs/vendors)
7. Health Authority Inspections

Authors

Lauren Ewen (team lead), Pam Bones, Mark Parker, Lindsay Watt, Louise Alford, Sandra Dunlavy, Kim Palmer, Deepti Naik.

Reprinted

April 2022