Endotoxin Test – Updated FDA Q&A document published
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We have previously reported on several occasions about the latest developments in the field of endotoxin testing. In recent years in particular, there have been a number of innovations and advancements, both scientifically and in terms of regulations. During such reviews, a wide range of questions usually arise regarding the changes and new requirements. Both at European level and within the US FDA, the authorities are endeavouring to answer such questions and to produce Q&A documents for this purpose.
Current Q&As of the US FDA
In March, the US FDA published a revised document entitled ‘Pyrogen and Endotoxins Testing: Questions and Answers’, which updates the original guidance. This update is driven, among other things, by the new and revised chapters of 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
The FDA stated that it has concluded that the published USP and AAMI documents, which describe methods and the calculation of limit values for pyrogen and endotoxin testing, provide the industry with adequate information. The Agency has therefore withdrawn the 1987 guidance document, as it no longer reflects the Agency’s current views on this matter. However, as the chapters of the pharmacopoeias and the standards do not address certain regulatory aspects, the FDA is providing supplementary information in this guidance/Q&A to explain our current position regarding the submission and maintenance of pyrogen and endotoxin test results for products regulated by the FDA.
Further inforomation
The complete Q&A document can be found at the webpage of the FDA.
Further news on the topic of Endotoxins:
