ICH Vets Another Pre-Step 2 Q3D Draft to Strengthen Consensus on Heavy Metal Standards

In mid-December, the ICH Q3D Expert Working Group (EWG) sent out a second, pre-Step 2 draft of its elemental impurities guideline to draw further input from constituent organizations on the challenging, broadly impactful issues it encompasses, with the target of achieving a draft that meets the Step 2 ICH consensus criteria by mid-2013.

In the cover letter to the new draft, the EWG explains that the input provided on the earlier draft sent out in December 2011 “was instrumental in developing revisions to improve the clarity and content of the guideline.”  The cover note includes a summary of the specific changes that were made in response to the feedback (see box below).

“At this time,” the EWG explains that it is looking for further comments on “major issues that could affect the development of a Step 2 guideline” and “additional suggestions for the improvement” of the current draft. The note clarifies that this current assistance in reviewing the document “does not replace the formal public comment period, which will occur during Step 3 of the ICH process.”

The EWG is particularly interested in feedback on the risk-based control threshold approach and on the risk assessment approach and calculation option examples incorporated into the draft.

Also of interest are “data driven comments” on the proposed permissible daily exposure (PDE) limits, and alternative approaches that could be implemented for large volume parenteral products.

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