With the introduction of new APIs like Semaglutide and Tirzepatide, how can a facility ensure it meets the standards for evaluating these raw materials?
For those materials that do not have a USP monograph, collaborating with a contract laboratory to fulfill the raw material requirements is essential. This session will explore the expectations for raw material evaluation and highlight the differences between raw materials with a monograph versus the absence of a monograph.
Our guest speaker, James Zellner, technical sales representative at ARL Bio Pharma, will also examine a manufacturer’s certificate of analysis (COA) and discuss how to develop an effective testing strategy.
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Learning objectives
- Outline expectations of raw material evaluations for GMP facilities
- Compare and contrast testing approaches when a monograph exists vs. the absence of a monograph
- Identify testing approaches for GLP1s
- Interpret a manufacturer’s COA
