Regulatory Authorities Discuss Elemental Impurities Standards

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Regulatory Authorities Discuss Elemental Impurities Standards

Developments in the standardization of elemental impurities have been seen in both the US and Europe in recent weeks. On August 29, EDQM announced it has decided to delay implementation of its 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 has been finalized. The guideline, in effect for new products since September 2008, was to go into effect for existing marketed products on Sept. 1, 2013.

In April 2012, the Ph. Eur. Commission had decided to reproduce the EMA guideline in Ph. Eur. Chapter 5.20 and to introduce a cross-reference to the chapter in the general monograph “Substances for pharmaceutical use (2034)” at a later date.
The revised general monograph, “Substances for pharmaceutical use (2034),” was adopted by the Ph. Eur. Commission in March 2013 for publication in Ph. Eur.Supplement 8.1, and therefore, would have become mandatory on April 1, 2014.  The publication would have made the requirements of the EMA guideline legally binding for all APIs. The Ph. Eur. Commission, however, decided to delay publication of the revised version of the general monograph to ensure continued consistency between the approaches of licensing authorities and the Ph. Eur.

In the US, the United States Pharmacopeial Convention (USP) posted a


of the second meeting of the USP Elemental Impurities Implementation Advisory Group. The Working Group discussed challenges companies may experience in the implementation of elemental impurities standards. The group has seen positive effects from ICH’s Q3D Step 2 guidance and has identified areas to be addressed including requirements for products with longer shelf lives, testing capacity, staff training, regulatory filing, and topical products.