This webinar was a preview of two soon to be re-issued IPEC Guides; the IPEC Certificate of Analysis Guide for Pharmaceutical Excipients and the IPEC Stability Guide for Pharmaceutical Excipients.
The primary goal of the IPEC Certificate of Analysis Guide for Pharmaceutical Excipients guide is to provide best practices for the preparation and appropriate use of a Certificate of Analysis (COA) for pharmaceutical excipients.
The webinar also reviewed the IPEC Stability Guide for Pharmaceutical Excipients. The primary goal of the Stability Guide is to offer best practices and guidance in the establishment of an excipient stability program; and is intended to provide excipient manufacturers with strategies for assessment of overall stability. It also provides an approach for a manufacturer to establish a stability study program which may be used to support regulatory filings, aid in maintaining the quality of the excipient, and define substantiate recommended storage conditions and shelf-life claims (e.g., re-evaluation date, expiration date, and use-by by date).
Learning/Awareness Objectives
> Overview of both the IPEC Certificate of Analysis Guide for Pharmaceutical Excipients and the IPEC Stability Guide for Pharmaceutical Excipients, including recent major changes
> Understanding of best practices for COA
> Understanding of excipient stability, the stability program for excipient and differences between excipient and API stability
> Define COA roles and responsibilities for the excipient manufacturer and distributor
> Clarification of key points and terminology for both guides (e.g., retest date, identification testing, compendial compliance)
Who should attend?
Personnel from excipient manufacturer, user and distributor regulatory, quality, R&D, formulation, purchasing, manufacturing and supply chain areas would benefit from attending this webinar.