FDA, the USA Drug Regulator, Published Q4B Evaluation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 14: Bacterial Endotoxins Text General Chapter.
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This annex is the result of the Q4B process for the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.6.14. Bacterial Endotoxins, JP 4.01 Bacterial Endotoxins Test, and USP General Chapter <85> Bacterial Endotoxins Test, can be used as interchangeable in the ICH regions subject to the following conditions:
Any of the three techniques can be used for the test. In the event of doubt or dispute, the gel-clot limit test should be used to make the final decision on compliance for the product being tested.
The Endotoxin Reference Standard should be calibrated to the current WHO (World Health Organization) International Standard for Endotoxin.
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