New Templates for GMP and GDP certificates published by EMA

Recommendation

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In May 2012 and in July 2012 the European Medicine Agency revised the Compilation of Community Procedures on Inspections and Exchange of Information.

The compilation is a tool for facilitating co-operation between the GMP inspectorates of the Member States and a means of achieving harmonisation. The procedures described provide the basis for national procedures that partly belong to the national GMP inspectorates' quality systems. These quality systems are based on a framework laid down in one of the documents of the Compilation. In July 2010 documents connected with Good Distribution Practice (GDP) inspections started to be added to the Compilation.

New templates for Wholesale Distribution Authorisation, GDP certificates as well as GDP non-compliance statements have been added in the above document. These templates refer to GDP for Medicinal Products. In addition, new templates for APIs (e.g. for Registration of manufacturers, importers or distributors of APIs) have been developed.

The procedure for dealing with serious GMP non-compliance information originating from Third Country Authorities or International Organisations is also new.

In addition to the above changes the 'Community (Union) Format for Manufacturer's Authorisation' has been modified to facilitate harmonised interpretation. The 'Union Format for GMP certificate' has been similarly modified to facilitate interpretation and also to accommodate entry of inspected manufacturing operations for active substances.

Source: EMA Document "Compilation of Community Procedures on Inspections and Exchange of Information"