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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
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