Wednesday, 10 April 2013

Endotoxin test harmonisation

ICH Guideline Q4B Annex 14, which permits the use of the harmonised USP, Ph. Eur. and JP endotoxin test chapters in any ICH region (as of May 2013), has been issued as the fourth and final part of the harmonisation process.

The guideline is titled “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.”

To this each authority will add a reference number. Within Europe this is: EMA/CHMP/ICH/529785/2010

The guidance can be found here: ICH endotoxin

The guideline refers to the three LAL test methods (tubridimetric, chromogenic and gel-clot), although it states that the gel-clot test remains the referee test.

Thanks to the ECA for the tip-off about this news.

Microbiology books Posted by Tim Sandle