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
Dr. Irwin B. Silverstein. Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.
For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. Since 1991, he has worked with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration.