In May, the European Medicines Agency published the ICH guideline "Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests – general chapter". This document contains the proposed texts submitted by the Pharmacopoeial Discussion Group (PDG).
Based on the evaluation of the Q4B Expert Working Group, the ICH 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. This recommendation will be effective under the following conditions:
To find out more please see the complete "ICH guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests – general chapter"