USP rejects appeals on elemental impurities update
pharmafile | February 4, 2013 | News story | Manufacturing and Production |Â Â USPÂ
The US Pharmacopeial Convention (USP) has rejected an appeal by drugmakers and suppliers of pharmaceutical ingredients to postpone publication of new chapters on elemental impurities.
The USP voted at a meeting on 7 January to uphold General Chapters <232> Elemental Impurities – Limits and <233> Elemental Impurities – Methods, which had originally been due to come into effect on 1 December.
The chapters lay out limits for metallic impurities in pharmaceutical preparations and cover analytical methods to determine them, but there has been concern that USP is finalising its guidance before the International Conference on Harmonisation (ICH) completes its draft Q3D Guideline which also covers the same territory.
Q3D has been updated throughout 2012 and is expected to be released as a second draft for public consultation in Jun 2013, which would put it on target for adoption in mid-2014.
The USP’s Executive Committee of the Council of Experts (CoE EC) postponed the official dates of the chapters in December 2012 to allow review time for the appeals, but concluded at its latest meeting that there was “no new data or evidence presented that justifies further consideration”. As a result a new official date of 1 February has been set, ending their postponement.
A consortium of industry organisations had lodged an appeal amid concern that moving ahead with implementation of the USP chapters without harmonisation with the ICH Q3D guideline could lead to regulatory and compliance issues, potential supply interruptions and added costs to manufacturers and patients.
The Coalition for Rational Implementation of the USP Elemental Impurities Requirements included excipient trade bodies IPEC Americas and IPEC Europe, the Generic Pharmaceutical Association (GPhA), the Consumer Healthcare Products Association (CHPA), the Society of Chemical Manufacturers & Affiliates – Bulk Pharmaceutical Task Force (SOCMA- BPTF), and the New Jersey Pharmaceutical Quality Control Association (NJPQCA).
The USP’s announcement was published on 28 January and can be viewed in full here.
Last year IPEC warned that some pharmaceutical manufacturers were asking excipient suppliers to provide metal impurity levels ahead of the ICH Q3D guideline implementation.
Phil Taylor
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