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The European Pharmacopoeia Commission has changed its approach on elemental impurities

Date:11 December 2013

The revision had followed a discussion at the Committee for Medicinal Products for Human Use (CMHP), the leading EU scientific committee involved in assessing marketing authorisation applications coordinated by the European Medicines Agency (EMA), writes Susanne Keitel, head of the Directorate for the Quality of Medicines of the council of Europe, in her article "Control of Elemental Impurities" in the November issue of "Pharmaceutical Technology Europe".

According to Keitel, the European Pharmacopoeia Commission considered it important not to proceed with a revision of Chapter 5.20 Metal catalyst or metal reagent residues until limits have been harmonised between regulatory authorities.


Background

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.
In its April 2012 session, the Ph. Eur. Commission decided to reproduce the EMA Guideline in Ph. Eur. Chapter 5.20 and to introduce a cross-reference to this Chapter in the general monograph Substances for pharmaceutical use (2034) at a later stage.
The reproduction of a Guideline in a Ph. Eur. Chapter does not make it legally binding as long as the Chapter is not referenced in a Ph. Eur. monograph. The revised general monograph Substances for pharmaceutical use (2034) that cross-references Chapter 5.20 had been adopted by the Ph. Eur. Commission at its March 2013 session for publication in Ph. Eur. Supplement 8.1. As a consequence, Chapter 5.20 would have become mandatory on the implementation date of the revised monograph, i.e. 1 April 2014, thus making the requirements of the EMA Guideline legally binding for all active pharmaceutical ingredients.
However, in view of the decision taken by the CHMP and to ensure continued consistency between the approaches of licensing authorities and the Ph. Eur., the Ph. Eur. Commission has decided to defer publication in Ph. Eur. Supplement 8.1 of the revised version of the general monograph Substances for pharmaceutical use (2034) that cross-references Chapter 5.20.

As a consequence, chapter 5.20 Metal catalyst or metal reagent residues will not now become legally binding as of 1 April 2014.


Source: "Control of Elemental Impurities" by Susanne Keitel in Pharmaceutical Technology Europe, November 2013

Web: http://images2.advanstar.com/PixelMags/pharma-tech-eu/digitaledition/11-2013.html#16

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