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FDA Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers



This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter <85> Bacterial Endotoxins Test, USP Chapter <161> Transfusion and Infusion Assemblies and Similar Medical Devices,and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72).

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