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
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. Dr. Silverstein established an excipient GMP certification program that was accredited by the American National Standards Institute (ANSI) and ran the program from 2001 till 2014.
His consulting also includes conformance assessments to site requirements for pharmaceutical manufacturers (finished drug makers). He performs gap analyses with respect to excipient GMP compliance for excipient manufacturers and has provided detailed guidance as to how to improve their conformance to excipient GMP requirements. He is an American Society for Quality (ASQ) Certified Quality Auditor (CQA) as well as ISO 9000 Certified Lead Auditor. He helped develop the IPEC-Americas auditor training programs for hourly and supervisory personnel. Irwin also serves as leader of the IPEC-Americas Excipient Learning Lab (ELL).