Recording from Wednesday, January 17, 2018

This webinar, originally recorded on January 14,2018, is an overview of the IPEC guide Qualification of Excipients for use in Pharmaceuticals. It reviews the general guidance section with emphasis on the regulatory assessment, manufacturing and packaging, and excipient specifications.

For Excipient Makers
Customer expectations for their product and the expectations for supporting information
Excipient development for use in finished product and specification requirements (so that the excipient manufacturer understands the information required by the user)

For Excipient users
The supplier qualification process for the pharmaceutical manufacturer (excipient user) - includes assessment, selection, and specification development