Pharmacovigilance & Drug Safety

PV Inspection and Audit Readiness

To determine that the marketing authorisation holder has personnel, systems and facilities in place to meet their pharmacovigilance obligations, to identify, record and address non-compliance which may pose a risk to public health, to use the inspection results as a basis for enforcement action, where considered necessary. The aim of a pharmacovigilance audit is to use objective evidence to assess the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system. The audit must be clearly documented and can only relyon verifiable evidence, such as written records and statements.