FDA Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers (Edition 2)

Title:
FDA Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers (Edition 2)

https://www.gmp-compliance.org/files/guidemgr/Pyrogen-and-Endotoxins-Testing--Questions-and-Answers_0.pdf

Origin/Publisher:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM310098.pdf

Content:
US FDA published a revised document on the topic of ‘Pyrogen and Endotoxins Testing: Questions and Answers’, which updates the original guidance. The background to this includes, amongst other things, the new or revised chapters of the USP <85> “Bacterial Endotoxins Test”, <161> “Medical Devices – Bacterial Endotoxin and Pyrogen Tests” and the recommendations of 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)”. In the current guidance, the FDA explains its view on the recommendations in the above-mentioned documents Translated with DeepL.com (free version)

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