Recording from Wednesday, January 22, 2020

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