Community procedures

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Compilation of European Union Procedures on Inspections and Exchange of Information

The European Medicines Agency is responsible for maintaining and publishing the Compilation of Procedures on behalf of the European Commission. The Compilation of Procedures is a collection of GMP inspection- related procedures and forms agreed by the GMP inspectorates of all the Member States and designed to facilitate administrative collaboration, harmonisation of inspections and exchange of inspection-related information. Article 3 of the GMP Directive, 2003/94/EC, requires Member States to take account of these procedures, and they are used as the basis for standard operating procedures of the quality systems established within the inspectorates themselves.

Queries? Send a question to the European Medicines Agency.

Table of contents


Compilation of European Union Procedures on Inspections and Exchange of Information

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Document(s) Language Status First published Last updated Effective Date
Compilation of Community procedures on inspections and exchange of information (English only) adopted 02/08/2008 11/12/2014  

Documents for the convenience of Inspectorates

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Document(s) Language Status First published Last updated Effective Date
Rapid alert notification of a quality defect / recall (English only) adopted 05/05/2009 11/03/2011  
Follow-up and non-urgent information for quality defects (English only) adopted 05/05/2009 11/03/2011  
Good-manufacturing-practice inspection report - Community format (English only) adopted 20/09/2006 11/03/2011