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Pharmacovigilance inspection program: Guidance for medicine sponsors

Version 1.0, September 2017

1 September 2017

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Records management

You should ensure you have appropriate processes in place to allow for the identification, retrieval and management of all documentation relating to pharmacovigilance activities. Documentation relating to adverse events and signal management should include any measures taken to investigate the issue, the timelines for those investigations and decisions on safety concerns. Our inspectors may ask to evaluate this documentation during the inspection process.

You are required to record all pharmacovigilance information and ensure it is handled and stored in a way that allows the information to be accurately reported, interpreted and verified. This includes information related to pharmacovigilance inspections - particularly inspection reports, close-out records and records related to implementing CAPAs.

We record pharmacovigilance inspection data, including inspection plans, finalised inspection reports and close-out records, as well as any evidence of confirmed deficiencies. We handle and store this information in a way that allows it to be accurately reported, interpreted and verified. Our records management system for documents related to pharmacovigilance inspection planning and reporting ensures the documents can be retrieved, and that measures taken to investigate deviations from regulatory compliance or safety concerns can be traced.

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