IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients

Tuesday, November 17, 2020 - 9:30am

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.

Learning Objectives

  • 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.


Irwin B. Silverstein, Ph.D.

Lead Trainer
IPEC-Americas Excipient Learning Lab

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 Brambora

Global Senior GMP Auditor
Novartis Pharma AG – Basel, Switzerland

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.

Cancellation Policy


Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org