GDF 2024 | D2S15 - The Bacterial Endotoxins Specification –Points to Consider

This presentation explained what bacterial endotoxins are and why they pose patient risks in injectable drug products. The session addressed how to control endotoxins in injectable drug products and provided guidance on setting acceptance criteria for release and stability endotoxin specifications. Key considerations for ensuring patient safety through proper endotoxin control were discussed throughout the regulatory framework.

Timestamps

00:44 – Why am I Here and What are Endotoxins?

05:50 – Setting the Acceptance Criteria

11:39 – Case Study 1

13:25 – Case Study 2

16:32 – Recap

Speaker:

Erika Pfeiler, PhD
Unit Supervisor
Division of Pharmaceutical Manufacturing Assessment VI (DPMA VI)
Office of Pharmaceutical Manufacturing Assessment (OPMA)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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