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GMP News No. 842
21 November 2006
Delegation of GMP-Inspectionswithin the EU
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:
The Compilation is available at the following address:http://www.emea.eu.int/Inspections/GMPCompproc.html