ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions
Table of contents
This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.
Keywords: Recognition pharmacopoeial tests, Q4B evaluation process
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ICH guideline Q4B Annex 4B on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Tests for specified micro-organisms - Step 5 (PDF/191.84 KB)
Adopted
First published: 01/06/2009
Last updated: 13/07/2017
Legal effective date: 01/06/2009
EMEA/CHMP/ICH/308817/2008 -
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ICH: Q 4 B Annex 1: Annex to regulatory acceptance of analytical procedures and/or acceptance criteria (RAAPAC) - Step 3 (PDF/38.32 KB)
Draft: consultation closed
First published: 01/06/2006
Last updated: 01/06/2006
EMEA/CHMP/ICH/222063/2006