Excipient GMP: The Industry Journey From Guides To Standards

Presenter: Bretta Lichtenhan, Surveillance and Advocacy Regulatory Affairs Expert, MilliporeSigma

Excipient GMP has evolved over the past ten years from guides to standards. The focus on the importance of excipient GMP is ever increasing. In March 2016, the European Guidelines on formalized risk assessment for ascertaining the appropriate GMP for excipients of medicinal products for human use became official. It is clear that regulatory bodies see the value in having the drug manufacturers understand and assess the risk of the excipients in their drug products as it relates to appropriate GMP.

As an excipient supplier our organization understands the regulatory framework and the needs of our customers as they relate to excipient GMP.

During this webinar you will learn about the evolution of excipient GMP from guides to standards. A review of the current excipient GMP standards will be covered; specifically, it will include an explanation of what the EXCiPACT™ certification scheme is and how it includes a standard for excipients. Additionally, a review of the currently published NSF/IPEC/ANSI 363 GMP excipient standard will be covered. Lastly, we’ll discuss and review our approach for providing Emprove® documentation to support our customers.