IV.A. 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.

The minimum requirements of the pharmacovigilance systems and the quality system are set out in the Commission Implementing Regulation (EU) No 520/2012 (IR) on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC. Risk-based audits of the pharmacovigilance system should cover all areas listed in Directive 2001/83/EC (DIR) and Regulation (EC) 726/2004 (REG). The specificities of the risk-based audits of the quality system [for pharmacovigilance activities] are as described in the Implementing Measures [IR Art 8,10, 11,12,13(1) for marketing authorisation holders, and IR Art 8,14,15,16,17(1) for the competent authorities in Member States and the Agency].

The overall description and objectives of pharmacovigilance systems and quality systems for pharmacovigilance activities are referred to in GVP Module I, while the specific pharmacovigilance processes are described in each respective Module of GVP.

In this Module, all applicable legal requirements are referenced in the way explained in the GVP Introductory Cover Note and are usually identifiable by the modal verb “shall”. Guidance for the implementation of legal requirements is provided using the modal verb “should”. This Module provides guidance on planning and conducting the legally required audits, and in respect of the operation of the EU regulatory network, the role, context and management of pharmacovigilance audit activity. This Module is intended to facilitate the performance of pharmacovigilance audits, especially to promote harmonisation, and encourage consistency and simplification of the audit process. The principles in this Module are aligned with internationally accepted auditing standards, issued by relevant international auditing standardisation organisations (1) and support a risk-based approach to pharmacovigilance audits.

Section IV.B. outlines the general structures and processes that should be followed to identify the most appropriate pharmacovigilance audit engagements and describes the steps which can be undertaken by marketing authorisation holders, competent authorities in Member States and the European Medicines Agency, to plan, conduct and report upon an individual pharmacovigilance audit engagements. This Section also provides an outline of the general quality system and record management practices for pharmacovigilance audit processes.

Section IV.C. provides an outline of the operation of the EU network in respect of pharmacovigilance audits.