Excipients
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:
- The USP Excipients Standards-Setting Process
- Gelatin and Gelatin Capsule Updates
- Excipient Monograph Modernization
- FDA Inactive Ingredient Database
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
Media Inquiries:
mediarelations@usp.org
Outcomes
- 02b 2015 USP Convention
- 02c Call for Candidates
- 02d Global Education and Training
- 03a USP Overview
- 03b USP Excipients Standards Setting Process
- 03c CHPA Overview
- 03d FDA/USP Spectral Libraries Update
- 03e FDA Inactive Ingredient Database Update
- 04a USP Priority Excipient Monograph Modernization Updates
- 04b EP Perspective: How to Develop a Monograph
- 04c FDA Monograph Modernization Initiative
- 04di GMIA Manufacturers Perspective
- 04diii USP Update on Gelatin Capsules
- 05 Standards Acquisition and Donor Recognition Program
- 07 USP Verification Program
- Overview of PQRI Excipient Survey
- USP Excipients Stakeholder Forum Meeting #2 Summary Slides