EDQM requires more Information on the Manufacturer's Localisation (DUNS/GPS) for CEPs

In our GMP News from 17. February 2011 we reported about the requirements for new EU Site Master File. One of these new requirements concerns the geographical indication of the location with GPS data or a DUNS number (Data Universal Numbering System).

The European Directorate for the Quality of Medicines and Health Care (EDQM) integrates this requirement and makes it binding from 15 April 2011 for any application or revision of a Certificate of Suitability (CEP). The reason given by the EDQM for this change is that in the past incorrect address indications (like missing or modified street numbers) have been noticed. The GPS coordinates or the DUNS number should facilitate the localisation of the manufacturing site in the future.

In the document "Information to applicants for CEPs- Data for localisation of manufacturing sites (GPS and DUNS), the EDQM explains which unities (for GPS coordinates) and which locations must be indicated and how to obtain these GPS coordinates. Even Google-Earth data can be used. An explanation for the DUNS number is given too but this number is not mandatory.

For further details please see the announcement of the EDQM.

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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