Industry coalition questions USP comments on elemental impurities harmonisation

29-Nov-2012 - Last updated on 11-Dec-2012 at 13:54 GMT

Coalition questions wisdom of USP elemental impurities timelines

The industry group that prompted the USP to delay new elemental impurities standards says even when completed, ICH Q3D will take time to implement.

On Tuesday the US Pharmacopeial Convention (USP) postponed the ‘official date’ for chapters <232> and <233> on elemental impurities after an appeal by a group concerned the unofficial implementation target - May 2014 - would mean they will not be harmonized with ICH Q3D.

The USP told us while the adjudication may affect the implementation date – which will be set in in the Jan/Feb 2013 Pharmacopeial Forum – it believes ICH Q3D will be finalized by June, 2014, after which its own standards can be updated accordingly.

Dave Schoneker, a member of the Coalition for Rational Implementation of the USP Elemental Impurity Requirements, disagreed with this interpretation.

He told in-pharmatechnologist.com that when completed ICH Q3D is unlikely to go into effect immediately and, even when it does, the guideline will not be as broad as the USP standards.

“It would be up to the regulators in each region to set up an implementation plan and timeline once the [ICH] guideline goes to step 4 and this obviously would take time after their proposed June 2014 date if USP is correct about the ICH timeline.

“This ICH guideline also would only initially apply to new drugs. On the other hand, if the USP makes their general chapters official on May 2014, all new and existing drugs relevant to USP's requirements would need to be in compliance with these requirements at that time which would appear to be significantly before the ICH Q3D guideline would have any real compliance impact.”

The USP committee is expected to discuss the appeal in January and while Schoneker welcomed this a move in the right direction, he said the coalition will need to resubmit its appeal against the May 2014 timeline when the implementation date is formalized in the Jan/Feb 2013 Pharmacopeial Forum next year.

Known unknowns

Schoneker also reiterated that: “The Coalition members have carefully assessed what it will take to implement the USP Elemental Impurity requirements listed in <232> and <233> and the Coalition believes that it is simply not possible to fully implement these requirements by May 2014 due to the complexity involved in all the steps needed to meet these requirements.”

He cited unknowns like the metal content of active pharmaceutical ingredients (APIs) and excipients used in existing drug products as one issue, explaining that without this data it will be difficult to predict “how many products may need to be reformulated or changed to use different suppliers of various raw materials.”

Schoneker also raised things like selecting the appropriate sample preparation and test methodologies as issues that still need to be resolved.

“The Coalition believes that there is not enough information available yet to be able to establish a reasonable implementation date and that this would be even more difficult if USP tries to move forward without being aligned and harmonized with ICH Q3D in both technical requirements and implementation timeline.”