Co-Processed Excipient Guide Overview
Webinar: Introducing the Co-processed Excipient Guide!
Friday, December 15, 2017 – 11:00am to 12:00pm EST
Featuring Joseph Zeleznik, Manager of Technical & Regulatory Affairs, Meggle USA, Inc., and Chair, IPEC-Americas QbD Committee
IPEC-Americas and IPEC Europe have jointly published a guide for excipient makers and users on co-processed excipients. This guide offers best practice and voluntary guidance on the development, manufacture and use of co-processed excipients and provides support to both manufacturers and users of co-processed excipients.
- Provide history of co-processed excipients (CPE)
- Discuss the need for a CPE Guide
- Discuss and define single-entity, mixtures/blends, and CPEs
- Are CPEs new or novel?
- Discuss regulatory implications of CPEs
- The Co-processed Excipient Guide organization and content
- List and discuss benefits of the Co-processed Excipient Guide
- Present CPE case study