ICH Q4B Annex 6 Uniformity of dosage unites general chapter - Scientific guideline

This annex is the result of the Q4B process for the Uniformity of Dosage Units General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedure for the uniformity of dosage units by regulatory authorities in the ICH regions. It describes special requirements for this test to be considered interchangeable for use in the ICH regions.

Keywords: Dosage units, content uniformity, pharmacopeia

Current effective version

ICH guideline Q4B annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on uniformity of dosage units - general chapter - Step 5

Adopted Reference Number: EMA/CHMP/ICH/645408/2008

Document history - First version (current)

ICH guideline Q4B annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on uniformity of dosage units - general chapter - Step 5

Adopted Reference Number: EMA/CHMP/ICH/645408/2008

ICH: Q 4 B Annex 6: To note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on uniformity of dosage unites general chapter - Step 3

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/645408/2008