News about GMP/cGMP

27.11.2020

Swissmedic: Clarification on the validity of GMP certificates

Swissmedic clarified on 20 November 2020 that GMP certificates issued after routine inspections in 2017 or 2018 are valid until 2021 or until the conduct of the next routine inspection.  


The clarification was made because companies often assume that the certificates are no longer valid if the inspection took place more than three years ago. This assumption results from the European approach to GMP certificates in the EU database EudraGMDP. Currently, routine inspections are carried out in a risk-based manner due to the COVID-19 situation. Therefore the usual frequency cannot always be maintained. Further information on the currently valid authorisation and the date of the last inspection can be downloaded in an Excel file from the Swissmedic website.


Source:

Swissmedic: Validity of GMP certificates 


 

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