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The risk-based approach to pharmacovigilance audits

A risk-based approach is one that uses techniques to determine the areas of risk, where risk is defined as the probability of an event occurring that will have an impact on the achievement of objectives, taking account of the severity of its outcome and/or likelihood of non-detection by other methods. The risk-based approach to audits focuses on the areas of highest risk to the organisation’s pharmacovigilance system, including its quality system for pharmacovigilance activities. In the context of pharmacovigilance, the risk to public health is of prime importance. Risk can be assessed at the following stages:

• strategic level audit planning resulting in an audit strategy (long term approach), which should be endorsed by upper management;
• tactical level audit planning resulting in an audit programme, setting audit objectives, and the extent and boundaries, often termed as scope, of the audits in that programme; and
• operational level audit planning resulting in an audit plan for individual audit engagements, prioritising audit tasks based on risk and utilising risk-based sampling and testing approaches, and reporting of audit findings in line with their relative risk level and audit recommendations inline with the suggested grading system

Risk assessment should be documented appropriately for the strategic, tactical and operational planning of pharmacovigilance audit activity in the organisation