USP postpones work on elemental impurities
pharmafile | December 11, 2012 | News story | Manufacturing and Production |Â Â Â
The US Pharmacopeial Convention (USP) has postponed the publication of new chapters on elemental impurities after an appeal by drugmakers and suppliers of pharmaceutical ingredients.
General USP Chapters <232> and <233> lay out limits for metallic impurities in pharmaceutical preparations and cover analytical methods to determine them, and were due to come into force on 1 December.
Now, the USP says it has held back the publication deadline “to allow adequate time for the executive committee of the Council of Experts to adjudicate and render a decision on three appeals related to the two general chapters”.
Opposition to the new chapters rests in the view that they will be at odds with the International Conference on Harmonisation (ICH) draft Q3D Guideline, which is expected to be finalised after the proposed implementation date for the two USP chapters.
Last month, the Coalition for Rational Implementation of the USP Elemental Impurities Requirements said: “many companies that manufacture finished pharmaceuticals, active pharmaceutical ingredients (APIs) and excipients have been evaluating what will be required to implement the draft metal impurity requirements being discussed by [USP and ICH]”.
“There are many complexities involved with implementing both the ICH Q3D and USP requirements and … it will take industry a significant period of time to gain an appropriate understanding of both the likely test methodology issues and the normal variability for the metals that actually exist in pharmaceutical ingredients before the requirements can be fully implemented,” it added.
Unilaterally moving forward with the USP requirements without harmonisation with the ICH Q3D guideline could lead to regulatory and compliance issues, potential supply interruptions and added costs to manufacturers and patients, according to the Coalition.
The Coalition includes representatives from 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).
Earlier this year, IPEC warned that some pharmaceutical manufacturers were jumping the gun and asking excipient suppliers to provide metal impurity levels ahead of the ICH Q3D guideline implementation.
Phil Taylor
