FDA publishes ICH Q4B Annex 14 for Interchangeable Endotoxin Testing between ICH Regions

In May 2013, 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" became effective (see our News from 10 April 2013). After the EMA (see the News from 15 October 2013), the FDA adopted and published the guideline too.

The chapter is based on the following documents:

  • European Pharmacopoeia (Ph. Eur.) 2.6.14:
    Supplement 6.6 (official January 1, 2010), Bacterial Endotoxins (reference 01/2010:20614).
  • Japanese Pharmacopoeia (JP): General Test 4.01 Bacterial Endotoxins Test as it appears in the JP Sixteenth Edition (March 24, 2011, The Ministry of Health, Labour and Welfare Ministerial Notification No.65).
  • United States Pharmacopeia (USP):
    General chapter <85> Bacterial Endotoxins Test, USP 33 Reissue (published April 2010 and official October 1, 2010).

After the withdrawal of the FDA guidance, the pharmacopoeial chapters are the main guidance documents for endotoxin testing, together with FDA's Q&A paper (see the News from 14 August 2013)

Please see the FDA document "Annex 14 Bacterial Endotoxins Test General Chapter" for further information.

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