EMA publishes ICH Q4B Annex 14 - Bacterial Endotoxin Tests

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:

  • 2.1.1 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.
  • 2.1.2 The USP, JP, and Ph.Eur. reference standards are considered interchangeable as they have been suitably calibrated against the WHO (World Health Organization) International Standard for Endotoxin.
  • 2.1.3 In the section Photometric quantitative techniques, Preparatory testing, Test for interfering factors, the user should perform the test on solutions A, B, C, and D on at least 2 replicates using the optimal conditions as recommended by the lysate manufacturer.

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"

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