Excipients
The United States Pharmacopeial Convention (USP) will be holding the first Excipients Stakeholder Forum on June 7, 2013 at USP–U.S. in Rockville, Maryland, USA. To expand the opportunity for stakeholder participation, USP will offer a web-based component for those who would like to attend the meeting remotely. Registration is free for both in person and remote attendance.
The USP Excipients Stakeholder Forum has been created to enable an exchange of information and perspectives between USP and users of USP standards, with the ultimate goal of improving USP standards. The Excipients Stakeholder Forum will provide an opportunity for manufacturers, distributors, and users of excipients to discuss topics in an open forum setting. USP hopes the forum will encourage excipients constituencies to work openly and directly with USP as well as collaborate with fellow stakeholders.
Discussion at the Stakeholder Forum will be focused on science and compliance topics specific to pharmaceutical excipients:
- Introduction to USP and its public standards-setting process
- Modernization of existing National Formulary excipient monographs
- USP’s role in excipient GMPs
- Update on implementation of elemental impurities General Chapters <232> and <233>
Objectives
- Extending opportunities for participation to a broad range of excipients stakeholders to ensure industry-wide input to USP
- Educating stakeholders on USP activities while helping USP staff understand excipients issues
- Providing information on emerging USP initiatives that might affect excipients stakeholders
Who Should Participate
Manufacturers, suppliers, and users of excipients, whether members of a trade organization or independent.
Venue
Classroom
USP–U.S.
Contact Information
Jessica Simpson
jcs@usp.org
Outcomes
- 2a Elemental Impurities Update
- 3a Global Science and Standards Division
- 3b Excipient Standard Setting Process
- 3d Spectral Library Update
- 4 Roundtable- BioPhorum Operations Group
- 4 Roundtable- International Organization of the Flavor Industry
- 4 Roundtable- International Pharmaceutical Excipient Council- Federation
- 5 Excipient Modernization
- 6a Medicines Compendium Overview
- 6b Excipients in the Medicines Compedium
- 7 Excipient Related General Chapters
- 8 Pharmacopeial Education
- USP Excipients Stakeholder Forum Summary Slides