GMP NEWS 2010

EDQM Announces the Suspension of Further CEPs

The EDQM announced the suspension of two CEPs after an inspection and the withdrawal of two CEPs. In all cases manufacturers from China and India are affected by these measures. You will find more here.

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Revision of EU GMP Guide Chapter 1 Published

The European Commission has published a proposal for the revision of Chapter 1 Quality Management Systems of the EU GMP Guide. The new draft includes comprehensive changes. Find the details here.

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When Will the New Variations Regulation Come into Operation?

Read here if and until when the former Variations Regulation is in operation or if the new version is already to be implemented.

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Riboflavin Test for Cleaning Validation - Standardisation regarding Information Sheet of VDMA

An information sheet by the VDMA (German Process Plant and Equipment Association) gives recommendations on the standardisation of the riboflavin test (test of cleanability). Read more here.

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Interpretation of the New Annex 1 to the EC GMP Guide by PIC/S

The revision of Annex 1 to the EC GMP Guide on sterile medicinal products was quite controversial. How the changes should be interpreted and implemented from the inspectors' viewpoint is presented in a new PIC/S "Recommendation GMP Annex 1 Revision 2008, Interpretation of the most important changes for the manufacture of sterile medicinal products" PI 032-2. Read more here.

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