The Importance of Pharmacovigilance Audits
and Audit Programmes

Pharmacovigilance Audits are systematic examinations of a marketing authorisation holder (MAH) pharmacovigilance system. This includes but is not limited to pharmacovigilance processes, the quality management system, vendor/partner management and compliance with regulatory requirements and industry standards.

Pharmacovigilance audits are a requirement as per GVP IV Pharmacovigilance Audits, under section IV.C.1.1.Requirement to perform an audit:

‘The marketing authorisation holder in the EU is required to perform regular risk-based audit(s) of their pharmacovigilance system [DIR Art 104(2)], including audit(s) of its quality system to ensure that the quality system complies with the quality system requirements [IR Art 8,10,11,12,13(1)]. The dates and results of audits and follow-up audits shall be documented [IR Art 13(2)]’.

The lack of an audit element of the Pharmacovigilance system is a risk which may include an inspection finding for the companies Quality department around the management of the PV audit program. The MAH need to consider if they have factored in the Pharmacovigilance department(s) into the company’s overall audit strategy, and have they been risk assessed according to the activity performed, if these have not been done, these should be incorporated into the audit program as soon as possible.

It is also recommended to perform a pharmacovigilance process review of current procedural documents. This review process can instigate improvements and updates for a Pharmacovigilance system which in turn makes the system inspection ready. It is strongly advised to bring in an external auditor or an independent person to the pharmacovigilance system with pharmacovigilance experience who asses the company’s ability to monitor and manage the safety of their products effectively and to identify any issues so that they can be addressed prior to an inspection.

Pharmacovigilance Audits

MAH’s must define their Pharmacovigilance Audit Universe. This Universe should be determined on a risk-based approach. This involves assessing partners, vendors and processes and determining their risk to a pharmacovigilance system. Risks can be assessed at the following stages:

Strategic level audit planning:

Strategic planning for a pharmacovigilance audit involves risk-based planning on the strategic, tactical, and operational levels. On a strategic level, the MAH assess their Audit Universe, determines the risk of each of their partner’s, vendors and processes. The audit strategy is a high level statement of how the audit activities will be delivered over a period of time, longer than the annual programme, usually for a period of 2-5 years.

Tactical level audit planning:

During the tactical planning stage, an audit plan is developed. This audit plan should address factors such as quality measures and critical processes within a pharmacovigilance system, areas of high risk, and areas that were not examined adequately during a previous audit. The rationale for the timing, periodicity and scope of the individual audits which form part of the audit programme should be based on the documented risk assessment.

Operational level audit planning:

Planning at the operational level results in a plan for individual audit engagements, prioritisation of individual audit tasks, use of risk-based sampling and approaches, and a report of the audit findings according to the level of risk.

The Importance of Pharmacovigilance Audits


In summary, pharmacovigilance audits are essential for maintaining regulatory compliance, safeguarding patient safety, ensuring product quality, driving continuous improvement, and preserving the reputation of pharmaceutical companies.

If this sounds like an interesting area that you may need help with or you want to know more about pharmacovigilance or are interested in working for us to help keep medicines as safe as possible contact us at and we’ll be more than happy to hear from you.
Jason Connell
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