Audit findings and the pharmacovigilance system ... - Canary Ltd

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Audit findings and the pharmacovigilance system ... - Canary

ISSN 2041-3661 1 7 A U G U S T 2 0 1 2 Main audit findings and the Pharmacovigilance System Master File: clarification of the legal requirements In Advisor issue 307 we presented an interpretation on the subject of whether or not major audit findings need to be included in the Pharmacovigilance System Master File (PSMF). It appeared to many who read this document that the Commission Implementing Regulation 520/2012 had reversed the unpopular requirement to note major audit findings in the PSMF. However, this interpretation is misleading and closer scrutiny of the legal requirements suggest otherwise. Dr Anya Sookoo, Expert Inspector, GCP & Pharmacovigilance at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has clarified the legal requirements in relation to pharmacovigilance audits. Indeed, three documents need to be considered when establishing exactly what should be done: • Commission Implementing Regulation 520/2012 • Directive 2001/83/EC as amended by Directive 2010/84/EU • Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance System Master File Below the requirements of these documents are clarified. Directive 2010/84/EU, Article 104(2) paragraph 2 This Directive states that “The marketing authorisation holder shall perform a regular audit of his pharmacovigilance system. Supplement He shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings, ensure that an appropriate corrective action plan is prepared and implemented. Once the corrective actions have been fully implemented, the note may be removed”. Commission Implementing Regulation 520/2012, Article 13 The text in the Regulation supplements, but does not replace the text in the Directive. It states that “1. Risk-based audits of the quality system shall be performed at regular intervals to ensure that the quality system complies with the quality system requirements set out in Articles 8, 10, 11 and 12 and to determine its effectiveness. Those audits shall be conducted by individuals who have no direct involvement in or responsibility for the matters or processes being audited. 2. Corrective action(s), including a follow-up audit page 2 Issue 307S ▲

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