Qualifying an Excipient Supplier; Alternatives to 2nd Party Site Audit

Wednesday, January 22, 2020 - 11:00am

The presenter discussed what a pharmaceutical company should do when their excipient supplier won’t allow an on-site audit. For various reasons, excipient manufacturers are not always able to accommodate site audits by all their customers. However, the FDA encourages - and may soon expect - that pharmaceutical companies include site audits as a part of their excipient supplier qualification process. Currently site audits of excipient manufacturers are encouraged by the Falsified Medicines Directive, which has recently been adopted as guidance by PIC/s. So, what is a pharmaceutical company to do?

This webinar introduced several alternatives to 2nd party audits that should satisfy current and emerging regulations in this area.

Learning Objectives

1. Identify alternatives to excipient manufacturer audit by the customer
2. Determine Quality Management System requirements for use of third-party audit and certification as part of a supplier qualification program
3. Identify appropriate controls for use of a food additive, dietary ingredient, or cosmetic GMP compliant material in lieu of an excipient


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.

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
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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