EMEA Revises Compilation of Community Procedures

GMP News No. 782

GMP News
30 August 2006

EMEA Revises Compilation of Community Procedures

In July 2006 the EMEA complemented the "Compilation of Community Procedures on Inspections and Exchange of Information", previously issued on 23 June 2006. The new update contains an introduction and information on procedures for rapid alerts following quality defects as well as "enhanced formats for the Manufacturing Authorisation and GMP Certificate".

With the compilation the European Commission intends to enhance the cooperation between national GMP inspectorates and to support European harmonisation. Procedures described in it are the basis for the individual EU Member States' procedures and partly form their GMP inspectorates' quality systems. The compilation is published by the EMEA on behalf of the European Commission.

The complete compilation can be found here:

Learn more about audits from a practical perspective for EU and US aspects – in the ECA 3-day education course How to Pass EU and FDA Inspections – GMP-Compliance Auditor in Barcelona, Spain, from 4-6 October 2006.

Wolfgang Heimes
On behalf of the European Compliance Academy (ECA)

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