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Lack of harmonization on impurities a concern, says industry group

By Gareth Macdonald , 14-Nov-2012
Last updated on 15-Nov-2012 at 09:18 GMT

An industry consortium has asked the USP to delay new elemental impurities chapters on concerns that lack of harmonization with ICH Q3D will create compliance difficulties, shortages and additional costs.

The United States Pharmacopeial convention (USP) announced the new guidelines in May  last year, commenting that the existing testing requirements are based on a "technique not sufficiently sensitive to detect a number of impurities at levels known to be toxic."

At the time Anthony DeStefano - USP's senior VP of compendial services - told in-Pharmatechnologist.comt the drug industry would have enough time to adapt to the new requirements, which come into effect in May 2014.

This view is not shared by drug and API makers according to an industry group - whose members include IPEC Americas, IPEC Europe, GPhA, CHPA, SOCMA’s BPTF and the NJPQCA - which asked the USP to delay the implementation of its rules on impurities earlier this week.

The group's main concern is that the USP will introduce its requirements before the International Conference on Harmonisation's (ICH) completes its own work on elemental impurities .

Despite the fact that the ICH guideline is still in the early draft form, the USP has decided unilaterally to move forward with implementation of their General Chapters <232> and <233> and call for implementation of the USP Elemental Impurity General Chapter requirements by May 1, 2014.

Since this is likely to be before the ICH Q3D guideline is expected to be completed, industry has serious concerns that moving forward with the USP requirements without harmonization with the ICH Q3D guideline could lead to regulatory and compliance issues, potential supply interruptions and added costs to manufacturers and patients.”

The group also said it plans to meet with the US Food and Drug Administration (FDA) this month to discuss its concerns, adding that it has asked the agency to help develop a harmonized approach to the implementation timeline.

It is hoped that the Coalition’s efforts will ultimately result in harmonization of the USP’s requirements with those being developed by the ICH Q3D EWG.

"As we move towards this goal the Coalition will continue to work on additional risk assessment tools, data collection and educational activities in the future to assist in the implementation of these requirements.”

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