Delegation of GMP-Inspections within the EU

GMP News No. 842

GMP News
21 November 2006
 

Delegation of GMP-Inspections within the EU

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

This compilation is a tool for facilitating the co-operation between the GMP inspectorates of the Member States and a means of achieving harmonisation. The procedures within it provide the basis for national procedures that form part of the national GMP inspectorates' quality systems. The contents of the Compilation of Procedures are constantly updated developed and agreed, under the co-ordination of the EMEA, by representatives of the GMP Inspectorates of each member state. Procedures related to Rapid Alerts and GMP Inspections are also part of this compilation (also see our GMP news of 30 August 2006).

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

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

 

Are you prepared for the next GMP Inspections? The ECA has just announced additional GMP Training Courses and GMP Conferences (all courses are recognized for the European GMP Certification Programme). Follow this link to find out more.

 
Author:
Wolfgang Schmitt
On behalf of ECA
  

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