USP Forms Elemental Impurities Advisory Group - - BioPharm International

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USP Forms Elemental Impurities Advisory Group


The US Pharmacopeial Convention (USP) has formed the Elemental Impurities Implementation Advisory Group and appointed members to the group from various regulatory agencies. The group will recommend implementations and general chapter adjustments to USP and will report to the Chemical Analysis Expert Committee.

According to USP, the Advisory Group was formed 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.” 

Dr. Roger Williams, EVP–CEO and Chair, Council of Experts, appointed the following members to the group:

  • Jon Clark, FDA
  • David Gaugh, GPhA
  • John Kauffman, FDA and ICH Q3D Rapporteur (current)
  • David Klug, IPEC–Americas
  • John Leighton, FDA
  • Robert Osterberg, USP Toxicology Expert Committee
  • John Punzi, CHPA
  • Mark Schweitzer, ICH Q3D Rapporteur (through Step 2)
  • Phyllis Walsh, NJPQCA 

USP will keep stakeholders informed through web postings on the Elemental Impurities Key Issues page, including summaries of the Advisory Group’s deliberations.

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