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.



 


  • Types of inspections
  • Inspection Conduct
  • Strategic Risk Planning

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