Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test

Presented by

Karen Zink McCullough of MMI Associates & Kevin L. Williams of BioMérieux

About this talk

Title: Preview of USP’s Informational Chapter, Guidelines on the Endotoxins Test Presenter: Karen Zink McCullough, MMI Associates The retirement of FDA’s 1987 Guideline on LAL testing left a number of gaps in the written body of knowledge on LAL testing. Some of these gaps include: Guidance on RSE:CSE standardization, Guidance on Training, Guidance on OOS test results, and Calculation of Endotoxin Limits. The proposed chapter, that will appear in the July/August issue of Pharmacopeial Forum, provides information and recommendations on these topics and more. This Webinar will provide an overview of the contents of this new informational chapter. Title: Regulatory Compliance of Alternative Methods Presenter: Kevin L. Williams, BIOMÉRIEUX Recombinant Horseshoe Crab Factor C (rFC) tests are endotoxin-specific alternatives to Limulus Amebocyte Lyste (LAL). The United States Food and Drug Administration included rFC in their Guidance for Industry in 2012 and in 2016 the European Pharmacopoeia followed suit. Recently, the Japanese Pharmaceutical and Medical Device Agency published a collaborative study demonstrating equivalence between rFC and LAL. This presentation will provide an overview of how alternative method validation of rFC methods is conducted in accordance to USP chapters < 1225 > and < 85 >.

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