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USP delays new elemental impurities standards after industry appeals

By Gareth Macdonald , 27-Nov-2012
Last updated on 27-Nov-2012 at 12:16 GMT

The USP has delayed new elemental impurities standards but is still confident they can be harmonized with ICH Q3D even if May 2014 implementation target is kept.

The two chapters on <232> elemental purities limits and <233> elemental impurities procedures were due to become becomes part of the "official compendia" recognized under US law and enforceable by the FDA on December 1.

However, this plan is on hold according to USP spokeswoman Laura Provan, who told in-Pharmatechnologist.com that: “The official date has been postponed until the Executive Committee of the Council of Experts can adjudicate the pending appeals on the topic.”

The appeals – which were lodged by an industry coalition composed of IPEC Americas, IPEC Europe, GPhA, CHPA, SOCMA’s BPTF and the NJPQCA earlier this month – centre on the date the chapters are due to become effective, May 2014.

The group is concerned that if chapters 232 and 233 are implemented before the ICH’s Q3D guideline is completed the lack of harmonization will result in “regulatory and compliance issues, potential supply interruptions and added costs to manufacturers.

Whether the postponement will impact the May 2014 target will “depend upon the outcome of the comments on the General Notices proposal and their consideration by the Council of Experts Executive Committee,” according to Provan, who said the committee will meet in January 2013.

ICH Q3D timelines

Even if the May 2014 date is maintained the USP still appears to be confident that its timeline will not differ too markedly from the ICH’s own plan.

Provan told us that: “To USP’s knowledge, ICH plans to issue a Step 2 document for comment in June, 2013 and a Step 4 document in June 2014.  USP’s planned May 2014 dates only precede ICH by one month. 

USP plans to work with the appropriate Expert Committee and Expert Panel to update its general chapter to align the elements of interest and their Permissible Daily Exposures with the ICH Guideline after the ICH working group resolves any issues raised through its public comment process.”

She also pointed out that Anthony DeStefano, the USP’s Senior Vice President of General Chapters and Healthcare Quality Standards, is a member of the ICH Q3D Working Group and has been involved in the discussions from the beginning.  

The industry coalition that lodged the appeal did not respond to in-Pharmatechnologist.com's request for comment ahead of publication.

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