List of Documents Needed during GVP Inspections

The EMA previously published a guidance for applicants / MAHs involved in GMP and GCP inspections. Now this document has been updated to also include Good Pharmacovigilance Practice (GVP) inspections. The guidance describes the necessary documents and information that must be made available via the IRIS portal. It has to be ensured that inspection sites are notified and that they are inspection ready and have relevant documentation, facilities and personnel readily available for the GVP inspection.

List of documents / information to be provided to GVP Inspectors

  • Written statement (via the IRIS Portal) that the site accepts to be inspected. All documents and databases required, including source documents, must be available for direct access by the inspectors.
  • The contact details of the contact persons for the inspection.
  • Current and up-to-date pharmacovigilance system master file (PSMF). However, the inspection team will request additional information and documents following the PSMF review. 
  • An updated organization chart.
  • All SOPs related to pharmacovigilance.
  • Compliance data for the 30-day reporting requirements. 
  • A list of any on-going clinical trial / post-marketing studies globally.

The documentation should be presented in a clear and concise manner and needs to support filter, search, copy and print functions.

More information is available in EMA´s Guidance for applicants / MAHs involved in GMP, GCP and GVP inspections and in the updated IRIS guide for applicants published on EMA´s GCP website.

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