Navigating Raw Material Testing in the Absence of a USP Monograph: Your Essential Guide to Partnering with a Contract Testing Laboratorys

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.

We will also examine a manufacturer’s Certificate of Analysis (CoA) and discuss how to develop an effective testing strategy.

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

-Certificate of Analysis

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