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

AdoptedLegal effective date: Reference Number: EMEA/CHMP/ICH/308817/2008

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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

AdoptedLegal effective date: Reference Number: EMEA/CHMP/ICH/308817/2008

English (EN) (191.84 KB - PDF)

First published: Last updated:
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ICH: Q 4 B Annex 1: Annex to regulatory acceptance of analytical procedures and/or acceptance criteria (RAAPAC) - Step 3

Draft: consultation closedReference Number: EMEA/CHMP/ICH/222063/2006

English (EN) (38.32 KB - PDF)

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