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.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.2.4. 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.3.1.3. 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
EMA GVP Module 4: