USP delays guidance on elemental impurities
pharmafile | June 4, 2013 | News story | Manufacturing and Production |Â Â Q3D, USPÂ
The US Pharmacopeial Convention (USP) has agreed to postpone the deadline for implementing two new chapters on elemental impurities in drug products until next year amid pressure from industry.
The two new USP General Chapters – <232> Elemental Impurities: Limits and <233> Elemental Impurities: Methods – were due to come into effect in February but will now not be implemented until 1 May, 2014.
There has been consensus for some time that the current analytical tests – which have been in use for decades – need to be updated. Meanwhile, there are currently no limits established for impurities such as lead, mercury, arsenic and cadmium in drugs and dietary supplements.
The chapters lay out limits for metallic impurities in pharmaceutical ingredients and preparations, and are intended to update the methodology used to test for them, but there has been concern that USP was pushing its guidance through before the International Conference on Harmonisation (ICH) completes its draft Q3D Guideline, which also covers the topic.
Q3D is expected to be released as a second draft for public consultation sometime this month, which would put it on target for adoption in mid-2014.
In a statement, the USP said it had taken the decision to “work closely with ICH Q3D to align their activities with the implementation of General Chapters <232> and <233>”, bringing it into line with the wishes of industry groups such as the International Pharmaceutical Excipients Council (IPEC).
Last year, IPEC and other groups published a position paper which argued 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.
USP said the postponement would also allow it to work with those affected by the new elemental impurity standards, adding that it plans to set up an advisory group on the implementation of <232> and <233> and ‘adjustments are expected’.
In a related development, USP has also said in a frequently-asked questions (FAQ) document that it will defer the proposed deletion of General Chapter <231> on Heavy Metals until the work on <232> and <233> is complete.
It also plans to omit other general chapters such as <251> Lead, <211> Arsenic, and <261> Mercury that address elemental impurities and are referenced in a number of USP National Formulary (NF) monographs.
Phil Taylor
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