USP Elemental Impurities Implementation Advisory Group - Meeting Summary

The USP Elemental Impurities Implementation Advisory Group was formed in June 2013 in accordance with the Bylaws of the USP Convention, which state, “The EVP–CEO may appoint advisory bodies to advance the work of the Council of Experts and the Convention and provide advice to staff on policy matters.” The goal of the Advisory Group is to consider implementation recommendations to USP as it relates to the General Notices provision, with the expectation that it will conclude its work expeditiously so that a new implementation date can be established. Against the background of the new ICH Draft Guideline "ICH Q3D - Elemental Impurities" published on 5 August 2013 (see our News dated 6 August 2013) the general chapter <232> and <233> need adjustments and the Group's recommendations are supposed to support an undelayed and smooth revision of the chapters.

The output of the Advisory Group's 2nd meeting held on 7 August was published on USP's website on 30 August. In a nutshell the results of the meeting are as follows:

  • USP drug product monographs provide solutions for drug product manufacturers but not for ingredient manufacturers. FDA representatives confirmed that API manufacturers should collaborate with FDA in order to find appropriate solutions for their unique issues.
  • The introduction of the revised general chapters <232> and <233> will be announced in the General Notices (GN) of the USP at a future date. As an appropriate date for mandatory introduction December 1, 2015 is recommended.
  • A stage or tiered implementation by dosage form was discussed.
  • The Advisory Group's proposals will be reviewed by the Expert Committee in October 2013.

The next meeting of the Advisory Group will be in late September 2013.

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