The Q3C ICH Guideline was finalised under Step 4 in July 1997, providing recommendations on the use of less toxic solvents in the manufacture of drug substances and dosage forms, and setting pharmaceutical limits for residual solvents (organic volatile impurities) in drug products. Maintenance Process

2023年11月1日 · Q4 - Q4B Pharmacopoeias/药典: Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions : Q4B：ICH区域所用药典文本的评价和建议: 阶段5: 2007.11.1: 有: Q4B Frequently Asked Questions: Q4B：常见问题与解答: 2012.4.26: Q4B Annex 1 (R1): Residue on Ignition/Sulphated Ash General Chapter

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.

This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedures for microbial enumeration tests by regulatory authorities in the ICH regions.

经q4b专家工作组（ewg）审核，ich指导委员会建议，欧洲药典附录2.9.38（筛分法测 定粒度分布）、日本药典附录3.04（粒度测定法 方法2.筛分法）及美国药典附录786（筛分法 测定粒度分布）中各自规定的分析方法，在ich区域中具有同等效力。

In November 2003, ICH established the Q4B EWG to evaluate and recommend pharmacopoeial texts that are proposed for use in the three ICH regions. The Q4B EWG anticipates that the PDG will be the principal source of pharmacopoeial text proposals.

In November 2003, ICH had established the Q4B EWG to evaluate and recommend pharmacopoeial texts to be proposed for interchangeable use in the three founding ICH regions (USA, European Union, Japan).

2017年9月27日 · The ICH Q4 guidelines are generally seen as one of the least successful of the ICH quality initiatives. ICH Q4 is split into Q4A (Pharmacopoeial Harmonization) and Q4B (Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions).

本文件描述了由Q4B 专家工作组(EWG)对所选的药典文本的评价和推荐程序, 希望藉此在各注册管理机构之间达成共识,使药典文本可在ICH各区域内互相替代。 如果的评价的结果是肯定的,ICH将以专题的形式发布附件(即Q4B 结果),附件中包括药典文本的具体信息和执行方法。 制定实施Q4B附件的目的在于避免企业进行重复繁琐的的试验。 在发布Q6A( 质量标准:新原料药和新药制剂的分析方法和接受标准:化学原料药)和Q6B( 质量标准:生物技术/生物制品的分析方法和接受标准) …

本文简要介绍了国际人用药品注册技术协调会( ich)q4 指导原则提出的背景意义、组织架构、附件的制定流程、附件内容和使用方法，以期为我国药监机构加入ich 后的中国药典的编制提供帮助。