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GMP Guide

Additional guidance on quality reviews and ongoing stability monitoring

The European Commission has issued for consultation two documents containing guidance on product quality reviews and ongoing stability studies, to be added to chapters one (quality management) and six (quality control) of the EU GMP Guide in Volume 4 of the Rules Governing Medicinal Products in the European Union1,2. The proposals have been adopted by the Ad Hoc GMP Inspectors Working Group, and the Pharmaceutical Committee has endorsed them through written procedure. Both documents were issued for consultation in December 2003 with a request for comments to be submitted to GMP@emea.eu.int and in parallel to Karin.Krauss@cec.eu.int before 15 June 2004.

The proposed guidance on quality reviews has been developed in response to experience of member states' inspectorates of quality problems with products on the market, that have led to recalls...

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