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30 August 2013

The European Pharmacopoeia Commission revises its strategy regarding the implementation of Chapter 5.20 "Metal catalyst or Metal reagent residues"

In their July session, the Committee for Medicinal Products for Human Use (CHMP) decided to delay the application of the current EMA Guideline on the specification limits for residues of metal catalysts or metal reagents (EMEA/CHMP/SWP/4446/2000) to existing marketed products until the ICH Q3D guideline for elemental impurities will have been finalised. The EMA Guideline is already applicable to new products since September 2008 and should have become applicable to existing marketed products as of 1 September 2013.

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