EMA Database: First GDP Non-Compliance Report published

Recommendation

Tuesday, 26 October 2021 9 .00 - 17.00 h

Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals - Live Online

All GMP and GDP certificates are listed in a database by the European Medicine Agency and all GMP and GDP authorities in Europe enter the GMP and GDP certificates via an interface into the EMA database called EudraGMDP. The database was extended a few months ago and now contains GMP Non-Compliance Reports beside GMP certificates. Now that the GMP database has already been extended, it is the turn of the GDP data. In total, 677 GDP certificates have been recently entered in the EudraGMDP

On 19 February 2014, the first wholesaler has been declared GDP non-compliant by the Czech authority. This is the first GDP Non-Compliance Report in the database. One may suppose that there will be further Non-Compliance Reports with regard to the GDP area soon. The data were put in the database only one day after the inspection on 18 February 2014. Part 2 of the Non Compliance Report states: "Wholesale distribution activity affected: Distributor does not have authorized storage facilities".

Source:EudraGMDP Database