Delegation of GMP-Inspections within the EU

GMP News No. 842

GMP News
21 November 2006
 

Delegation of GMP-Inspectionswithin the EU

 
The possibility to delegate the performance of a GMP inspection(applicable to centrally authorised products) in third countries is nowalso part of the European Medicines Agency (EMEA) "Compilation ofCommunity Procedures on Inspections and Exchange of Information".

This compilation is a tool for facilitating the co-operation betweenthe GMP inspectorates of the Member States and a means of achievingharmonisation. The procedures within it provide the basis for nationalprocedures that form part of the national GMP inspectorates' qualitysystems. The contents of the Compilation of Procedures are constantlyupdated developed and agreed, under the co-ordination of the EMEA, byrepresentatives of the GMP Inspectorates of each member state.Procedures related to Rapid Alerts and GMP Inspections are also part ofthis compilation (also see our GMP news of 30 August 2006).

The new procedure will be used for the delegation of responsibilityfor conducting an inspection for centralised products in third countriesin case the responsible Member State is unable to carry out theinspection.

The new document can be found here:
http://www.emea.eu.int/Inspections/docs/CoCP/CoCP_DelegationGMPinspCAP.pdf

The Compilation is available at the following address:http://www.emea.eu.int/Inspections/GMPCompproc.html

 

 
Author:
Wolfgang Schmitt
On behalf of ECA
  

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