International Excipient Workshop

Excipient Quality Control, Testing, and International Harmonization
July 20 – 21, 2009
USP Headquarters, Rockville, Maryland

Overview

Sadly, diethylene glycol (DEG) adulteration has struck yet again, causing over 80 deaths in Nigeria in 2008. To better protect public health, USP collaborated with the Food and Drug Administration (FDA) to update and strengthen the USP Glycerin monograph. Experts from USP and FDA will discuss the proactive approach taken to detect adulteration of glycerin and other at-risk excipients with DEG or ethylene glycol (EG).

Expert presenters will also discuss the challenges in developing Excipient Compendia Monographs for the 21st century from compendial, regulatory, and industry perspectives starting with glycerin and other at-risk excipients. The discussion will extend to new types of compendial monographs needed for excipients being used in approved dosage forms. The roles of science and technology in facilitating revision of current monographs and developing new ones will be considered.

The workshop will also focus on the challenges related to the global sourcing of excipients from safety and performance perspectives, and the impact of the global supply chain on multi-source excipient equivalence. Discussions will conclude with an overview of the effective use of harmonized monographs to reduce the testing burden for pharmaceutical excipients.

Agenda

Click here  (326KB) for the most up–to–date workshop agenda (as of July 10, 2009).

Presentation Abstracts

• Gregory E. Amidon and Eric Schmitt: Future of Excipient Performance Testing in USP: Excipient Performance Chapter <1059>  (32KB)
• Lawrence H. Block New Excipient Development from the USP Perspective  (16KB), Is There A Problem with Multi-Source Excipient Equivalency?  (16KB)
• Anne Gayot: European Pharmacopeia Perspective on Functionality-Related Characteristics  (20KB)
• Mansoor A. Khan: Excipient Challenges in the 21st Century: An FDA Perspective  (15KB)
• Iain Moore: Excipient Certification and Supply Chain Security  (16KB)
• V. Srini Srinivasan: USP Verification Program for Excipients  (15KB)
• Hiroshi Tokunaga, Ph.D.: Japanese System on GMP's Applied to Excipients  (16KB), Japanese Pharmacopeia Update  (15KB), and Japanese Pharmacopeial Perspective on International Harmonization and Excipient Performance  (15KB)
• Jiasheng Tu: Regulatory Aspects on Pharmaceutical Excipients in China  (16KB)
• Ranga Velageleti: Excipient Innovation, Classification, and Regulatory Acceptance  (17KB)
• Steven Wolfgang: Regulatory Perspective on Assuring Excipient Quality  (17KB)

Presentations

• Session I presentations  (6.1MB)
• Session II presentations  (1.3MB)
• Session III presentations  (1.7MB)
• Summary and Next Steps  (1.1MB)

Hotel Information

All workshop activities will take place at the USP Meetings Center located at USP's Headquarters in Rockville, Maryland. If you require overnight accommodations, take advantage of special corporate rates at two nearby hotels listed below. Both properties are located within walking distance of the Twinbrook Metro Rail Station and the USP Meetings Center. Be advised that the USP corporate rate is subject to hotel availability.

Hilton Washington, D.C. / Rockville
1750 Rockville Pike, Rockville, MD 20852
USP Corporate Rate: $189 per night, plus taxes
Main Phone: (301) 468–1100

The Legacy Hotel
1775 Rockville Pike, Rockville, MD 20852
USP Corporate Rate: $189 per night, plus taxes
Main Phone: (301) 881–2300

Contact Information

For additional information or support, email