The presenters provided an overview of the soon-to-be-published IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients.
Lack of a unified industry approach to certification body qualification has resulted in pharmaceutical companies independently developing their own approach, which is subject to scrutiny during regulatory agency inspections. This Guide facilitates a consistent approach by excipient users to the qualification of an excipient-certification scheme owner (SO) and certification body (CB). This webinar will present the minimum criteria for the qualification of an excipient-certification SO and CB, which should be useful to excipient users in their own qualification of the GMP certificates issued by a CB.
- Define minimum qualification criteria for an excipient-certification SO and CB.
- Identify minimum information needed by excipient users to qualify a SO as well as the CBs who conduct and issue excipient GMP certificates and audit reports.
- Become familiar with content and use of the template associated with the Guide.
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.
Jeffrey is a quality lead auditor with nearly two decades of international GMP auditing experience. He has co-authored the United States national standard for excipient GMP (NSF/IPEC/ANSI 363) as well as the EXCiPACT standards for excipient GMP and GDP.