Harmonisation of EMEA GMP/GDP and GCP Inspectors Groups

GMP News
29 August 2007
 

Harmonisation of EMEA GMP/GDP and GCP Inspectors Groups

 
At the Heads of Medicines Agencies meeting in Lisbon in July 2007 it was decided that the names of the Ad Hoc GMP/GDP and the GCP Inspection Services Groups should be harmonised and it was agreed that these groups should therefore be called the GCP Inspectors Working Group and the GMP/GDP Inspectors Working Group.
 
Mandate, objectives and rules of procedure for the new Inspectors Working Groups were recently published and can be found in the following documents:
 
http://www.emea.europa.eu/Inspections/docs/23948607en.pdf
http://www.emea.europa.eu/Inspections/docs/47030206en.pdf
 
Co-operations with the European Commission, the EMEA and Heads of Medicines Agencies are specified and composition and rules of participation are also defined.
 
According to Directives 2001//20/EC respectively 2001/83(2)/EC conclusions reached following a GCP or GMP inspection are recognised and valid throughout the Community. The Inspectors Working Group provide input and recommendations on all matters relating directly or indirectly to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) irrespective of the marketing authorisation procedure through different reporting lines as indicated in the documents.
 

Hear essential aspects about the organisation, management and the inspection of clinical trials and IMP distribution in the ECA Education Course:

During this course, the important interfaces between GMP and GCP will be elaborated.

Learn more about GMP and GDP inspections, audits and related topics in the following ECA course:

 
Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
 

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