EMA GVP Module 4

Guideline on good pharmacovigilance practices (GVP) Module IV – Pharmacovigilance audits (Rev 1):

Introduction:

The entry into force of the new legislation on pharmacovigilance in July 2012, established legal requirements for competent authorities in the Member States and the European Medicines agency (the Agency) and marketing authorisation holders to perform audits of their pharmacovigilance systems [DIR Art 101(2), Art 104(2), REG Art 28f], including risk based audits of their quality systems [IR Art 13 (1), Art 17 (1)].

For the purposes of this Module reference to pharmacovigilance audit(s) and pharmacovigilance audit activity(ies) are deemed to include pharmacovigilance system audits and audit(s) of the quality system for pharmacovigilance activities. 

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Table of contents

IV.A. Introduction

IV.A.1. Terminology 

IV.B. Structures and processes

IV.B.1. Pharmacovigilance audit and its objective

IV.B.2. The risk-based approach to pharmacovigilance audits

IV.B.2.1.Strategic level audit planning

IV.B.2.2. Tactical level audit planning

IV.B.2.3. Operational level audit planning and reporting

IV.B.2.3.1. Planning and fieldwork

IV.B.2.3.2. Reporting

IV.B.2.4. Actions based on audit outcomes and follow-up of audits

IV.B.3. Quality system and record management practices

IV.B.3.1. Competence of auditors and quality management of audit activities

IV.B.3.1.1. Independence and objectivity of audit work and auditors

IV.B.3.1.2. Qualifications, skills and experience of auditors and continuing professional development

IV.B.3.1.3. Evaluation of the quality of audit activities

IV.B.3.2. Audits undertaken by outsourced audit service providers

IV.B.3.3. Retention of audit reports

IV.C. Pharmacovigilance audit policy framework and organisational structure

IV.C.1. Marketing authorisation holders in the EU

IV.C.1.1. Requirement to perform an audit

IV.C.1.1.1. The qualified person responsible for pharmacovigilance in the EU (QPPV)

IV.C.1.2. Competent authorities in Member States and the European Medicines Agency

IV.C.1.2.1. Requirement to perform an audit

IV.C.1.2.2. Common methodology 

IV.C.1.2.3. The Pharmacovigilance Risk Assessment Committee (PRAC)

IV.C.2. Requirements for audit reporting in the EU

IV.C.2.1. Reporting by the marketing authorisation holder

IV.C.2.2. Reporting by competent authorities in Member States and the Agency

IV.C.3. Confidentiality

IV.C.4. Transparency

EMA GVP Module 4: