Upcoming Webinar
Navigating Raw Material Testing in the Absence of a USP Monograph: Your Essential Guide to Partnering with a Contract Testing Laboratory
Find out how contract laboratories can help facilities meet the raw material evaluating standards in this webinar

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.

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

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