FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing

Recently, the FDA has withdrawn their guidance from 1987 because it no longer reflects the Agency’s current thinking on the topic.

Now, the FDA has published a new Guidance for Industry with question and answers on Endotoxin and Pyrogen Testing, providing recommendations for biological product, drug, and device firms. It is supposed to address 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).

These three documents describe the fundamental principles of the gel clot, photometric, and kinetic test methods, and recommend that appropriate components and finished products be tested for the presence of pyrogens and endotoxins.

This guidance is not meant to be a document for the general and complete subject of endotoxin and pyrogen testing. It rather addresses those issues that are possibly subject to misinterpretation and are not covered in compendial procedures or in currently available guidance documents.

Generally, FDA found that the existing documents of USP and AAMI describe the methods in an appropriate way, but they do not address certain regulatory perspectives. With this Q&A guidance, FDA wants to provide supplemental information to explain FDA's current thinking regarding the submission and maintenance of pyrogen and endotoxins testing for FDA-regulated products.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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