ICH Q4B Annex 14 Bacterial endotoxins tests - Scientific guideline

This annex is the result of the Q4B process for the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial bacterial endotoxins test procedures by regulatory authorities in the ICH regions.

Keywords: Bacterial endotoxins tests, pharmacopoeia

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use...

Adopted Reference Number: EMA/CHMP/ICH/529785/2010 Legal effective date: 01/05/2013 Summary:

This annex is the result of the Q4B process for the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Document history - First version (current)

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use...

Adopted Reference Number: EMA/CHMP/ICH/529785/2010 Legal effective date: 01/05/2013 Summary:

This annex is the result of the Q4B process for the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Draft 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 - Step 3

Draft: consultation closed Consultation dates: 24/09/2010 to 01/12/2010 Reference Number: EMA/CHMP/ICH/529785/2010 Legal effective date: 01/12/2010 Summary:

This annex is the result of the Q4B process for the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).