ICH starts consultation on elemental impurities guidance
pharmafile | August 7, 2013 | News story | Manufacturing and Production | ICH, Q3D, Taylor, USP
The International Conference on Harmonization (ICH) has started the consultation period on its long-awaited guidance on elemental impurities, a couple of months later than expected.
The document – called ICH Q3D – Impurities: Guideline for Elemental Impurities – lay out limits for metallic impurities in pharmaceutical ingredients and preparations and detail the testing procedures used to detect and measure them.
Q3D has now entered what is known as step 2b of a five-step implementation process, prompting a six-month comment period that represents the first major opportunity for industry and other stakeholders to have their say on the guidance.
Thereafter the guidance goes back to ICH for modification based on the feedback received, and a new finalised guideline is prepared. Once the final draft is adopted by ICH, it is then published and comes into effect, and on current schedules that should occur sometime in the middle of 2014.
The aim of the document is to provide a single approach for controlling metal impurities – including a list of specific metals to be limited and the appropriate limits for these metals – that will be the same in the US, Europe and Japan and so avoid uncertainty and duplicative testing procedures.
The guideline covers three main areas: toxicity testing; establishing Permitted Daily Exposure (PDE) limits for impurities of toxicological concern; and process controls to limit the introduction of impurities into the medicinal product during manufacturing.
The guide notes that elemental impurities can be introduced intentionally into medicinal products during synthesis or may be present as contaminants, for example arising through interactions with processing equipment.
With ICH now at the 2b stage it is expected that the US Pharmacopeial Convention (USP) will start the process of finalising its own guidance in this area, which is contained in two USP General Chapters – <232> Elemental Impurities: Limits and <233> Elemental Impurities: Methods – which had been due to come into effect earlier this year.
Concerns about a possible divergence between USP and ICH guidance prompted the creation of a group representing the interests of excipient suppliers, pharma manufacturer and fine chemicals companies – collectively called the Coalition for Rational Implementation of the USP Elemental Impurities Requirements – to lobby for a harmonised approach.
Last year, excipient trade body 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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