Increasing Number of GDP Non-Compliance Certificates

Recommendation

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The EudraGMDP Database contains GMP and GDP Compliance and Non-Compliance reports. So far a lot of GMP information has been published by the EU authorities but less about GDP compliance. Every EU Member State Inspectorate is asked to publish their GMP and GDP Inspection results. This will allow other authorities and industry to check the compliance status of certain companies.

A number of EU authorities have not published their GDP data information yet. However, progress can be seen also with regard to GDP compliance certificates and GDP non-compliance reports. From January 2016 until today six GDP non-compliance reports have been published. The Czech authority published three, the Danish authority two and a German inspectorate one GDP non-compliance report.

The current reports are not very detailed. However, some information can be found. For instance, for the company Ya Medicare in Winsen Germany the inspectors state: "The company has in general failed to comply with good distribution practice as they did not use the described quality system. The company has written procedures but was not able to show an adequate documentation for acting according to the procedures. Further the company does not have relevant documentation for storage and transport under correct temperature, a system for ensuring that they only obtain their supplies of medicine from companies with a valid WDA/MIA or a system for ensuring that they only supply medicines to companies with a valid WDA or a valid license to supply medicinal products to the public." The information provided in the report is very helpful in order to understand the nature of the non-compliance.

EudraGMDP is available in part for public. In order to get more detailed information please visit EudraGMDP.