ICH Q4B Annex 12 Analytical sieving - Scientific guideline

This annex is the result of the Q4B process for the Analytical Sieving General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial analytical sieving procedures by regulatory authorities in the ICH regions.

Keywords: Analytical sieving, pharmacopoeia

Current effective version

ICH guideline Q4B annex 12 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on analytical sieving - general chapter - Step 5

Adopted Reference Number: EMA/CHMP/ICH/730808/2009 Legal effective date: 01/12/2010 Summary:

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

Document history - First version (current)

ICH: Q 4 B Annex 12: Analytical sieving general chapter: Annex 12 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on analytical sieving general chapter - Step 3

Draft: consultation closed Consultation dates: 01/11/2009 to 28/02/2010 Reference Number: EMEA/CHMP/ICH/730808/2009

ICH guideline Q4B annex 12 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on analytical sieving - general chapter - Step 5

Adopted Reference Number: EMA/CHMP/ICH/730808/2009 Legal effective date: 01/12/2010 Summary:

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