EMEA Develops GMP Database

GMP News No. 805

GMP News
2 October 2006
 

EMEA Develops GMP Database

 
As the EMEA points out on its website, "the pharmaceutical legislation specifically refers to a number of information technology systems for which the EMEA was given the responsibility to implement certain projects. Directives 2004/27/EC and 2004/28/EC provide for a database on manufacturing and import authorisations, GMP certificates and non-GMP compliance information, currently under development as the EudraGMP database."
 
With this database the authority wants to harmonise the receipt and recording of manufacturing authorisations and GMP certificates. The exchange of inspection-related data will also help both the EMEA and the member states in planning their inspection schedules. The facilitated joint access to this information will enable an optimised use of the existing resources and contribute to a reduction of multiple inspections, especially in third countries.
 
With about 20,000 importers and manufacturers within the European Economic Area (EEA), the Agency expects up to 10,000 entries per year. Besides, the database has to be updated continually due to inspections in third countries and the new GMP requirements on active ingredients and certain excipients.
 
The competent authorities within the EEA will have unlimited read/write access to the EudraGMP database, whereas the general public will be able to view information that is not of confidential nature. Moreover, discussions with MRA partners are planned for the near future - with the goal to replace the paper exchange of certificates.
 
A first version of this database is planned to go online at the end of this year.
 
The complete document can be found here:
www.emea.eu.int/Inspections/EudraGMP.html

Compiled by:
Wolfgang Heimes
On behalf of ECA
 

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