ICH Q4B Annex 14: Bacterial Endotoxin Tests

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 has been adopted by the European Medicines Agency, according to the ECA.

The document allows for 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. The proviso is that the gel-clot test remains the reference test.

Furthermore, 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.

To view the document go to EMA

Posted by Tim Sandle