抗生素中相关杂质质量标准制定的指导原则【中英】.doc

30 June 2012 EMA/CHMP/CVMP/QWP/199250/2009 corr Committee for Medicinal Products for Human Use (CHMP)/ Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on setting specifications for related impurities in antibiotics 抗生素中相关杂质质量标准制定的指导原则 Final 定稿 Draft Agreed by Quality Working Party 2010 年 5 月质量工作中批准草案 May 2010 Adoption by CHMP for release for consultation 2010 年 6 月 24 日被人用药委员会采纳，公布征求意见稿 24 June 2010 Adoption by CVMP for release for consultation 2010 年 7 月 15 日被兽用药委员会采纳，公布征求意见稿 15 July 2010 End of consultation (deadline for comments) 2011 年 1 月 31 日结束征求意见 31 Jan 2011 Agreed by Quality Working Party 2012 年 5 月质量工作组批准 May 2012 Adoption by CHMP 2012 年 5 月 14 日被人用药委员会采纳 14 May 2012 Adoption by CVMP 2012 年 6 月 14 日被兽用药委员会采纳 14 June 2012 Date for coming into effect 2013 年 6 月 30 日生效 30 June 2013 学习之名 （译注） Table of contents 目录 Executive summary 概要 1. Introduction (background) 1、 背景介绍 2. Scope 2、范围 3、 法规依据 3. Legal basis 4、 一般要求 4. General requirements 5. Impurity profiling and reporting, identification and qualification thresholds 5、杂质分布以及报告、鉴别和界定阈值 6. New applications and variations 6、 新申请和变更 7. Specifications for medicinal products 7、制剂产品质量标准 8. Analytical procedures 8、 分析方法 Definitions 定义 Annex 1: Explanatory note regarding thresholds. Annex 2: Thresholds Annex 3: Example of “fingerprint chromatogram” approach to control very complex impurity profiles 附件 1：关于阈值的注释 附件 2：阈值 附件 3：利用基于 “指纹图谱”的方法对非 常复杂的杂质分布进行控制举例 Executive summary 概要 Antibiotics active substances currently on the market are produced by fermentation, by fermentation followed by one or more synthetic steps (semi-synthetic substances) or by chemical synthesis. Fermentation processes are, in comparison to synthetic processes, more variable and less controllable, so the impurity profile of an active substance whose manufacturing process involves fermentation may be more complex and less predictable than that of a purely synthetic product. For this reason fermentation products and semi-syntheti