21/22 November 2023
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.
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.