USP Workshop—Impurities, Adulteration, and the Changing Role of USP in Global Drug Quality

Impurities and adulteration in drug products and dietary supplements can, and have, posed well–publicized threats to public health. This interactive USP workshop provided an open forum for dialogue on current issues as well as future directions for related standards-setting activities.

Topics

  • USP's Elemental Impurities initiative and its future progression
  • Case studies on economically motivated adulteration, including heparin and diethylene
    glycol and the roles of pharmaceutical companies, regulators, and pharmacopeias in preventing counterfeiting
  • Industry and regulatory perspectives on regulating genotoxic impurities in
    pharmaceutical products
  • Issues related to the characterization of complex excipients, including co-processed excipients and the role of functionally-related characteristics in specification setting
  • Issues, challenges, and future directions for the identification of biological and control
    of their impurities

When: November 13–14, 2010

Where: AAPS–PSWC 2010, Morial Convention Center; New Orleans, LA, USA

Agenda

Presentations:

Participants: Professionals working in or with

  • Pharmaceutical Characterization
  • Pharmacopeial Science
  • Biologics Characterization and Testing
  • Quality Assurance & Quality Control
  • Pharmaceutical Analysis and Testing
  • Regulatory Affairs
  • Supply–Chain Management
  • Excipient Characterization