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News about GMP/cGMP

2012-06-29

EMA: New GDP documents in CoCP

The Compilation of Community Procedures on Inspections and Exchange of Information (Revision 14) (CoCP) has been adopted on 25 May 2012 and will enter into force in January 2013. Various new "Forms used by regulators" were added.

 

This regulatory guideline works as a tool for facilitating 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.
In July 2010 documents connected with Good Distribution Practice (GDP) inspections started to be added to the Compilation.

Newly added in the CoCP are the following "Forms used by regulations":

  • Union Format for a Wholesale Distribution Authorisation,
  • Union Format for a GDP Certificate,
  • Union Format for a GDP Certificate for Active Substances,
  • Statement of non-compliance with Good Distribution Practice,
  • Statement of non-compliance with Good Distribution Practice of a distributor of active substances for use as starting materials in medicinal products for human use
  • Union Format for Registration of Manufacturer, Importer or Distributor for Active Substance (used in Medicinal Products for Human Use).

Also newly added is  the document "Procedure for Dealing with Serious GMP Non-Compliance Information Originating from Third Country Authorities or International Organisations".

If you are interested in more details please see the original document.

Source:

EMA: Compilation of Community Procedures on Inspections and Exchange of Information

 

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