International Excipient Workshop—Excipient Quality Control, Testing, and International Harmonization

Presenters discussed the challenges in developing standards from compendial, regulatory, and industry perspectives—starting with glycerin and other at-risk excipients. The discussion extended to new types of compendial monographs needed for excipients that were in use in approved dosage forms.

Topics:

  • Proactive detection of adulteration of glycerin and other at-risk excipients with DEG or ethylene glycol (EG)
  • Challenges in developing excipient monographs for the 21st century from compendial, regulatory, and industry perspectives
  • Challenges related to the global sourcing of excipients from safety and performance perspectives
  • Impact of the global supply chain on multi-source excipient equivalence
  • FDA GMP guidance and international regulatory positions on excipients as they relate to revisions to the USP <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients <1078>
  • Proposed USP Chapter <1059> Excipient Performance

When: July 20–21, 2009

Where: USP Headquarters; Rockville, MD, USA

Agenda

Presentations:

Participants: Professionals working in or with

  • Excipient Manufacturers
  • Pharmaceutical Manufacturers
  • Excipient Distributors
  • Excipient Suppliers
  • Excipient Repackagers
  • Regulatory Affairs Professionals
  • QA/QC Professionals
  • Formulations Scientists
  • Materials Scientists
  • Academic Researchers