抗生素中有关杂质质量标准设定指南◆中英.docVIP

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 抗生素中有关杂质质量标准设定指南 Final最终版本? Draft Agreed by Quality Working Party May 2010 质量工作组通过草案 2010年5月 Adoption by CHMP for release for consultation 24 June 2010 CHMP同意公开征求意见 2010 Adoption by CVMP for release for consultation 15 July 2010 CVMP同意公开征求意见 2010 End of consultation (deadline for comments) 31 Jan 2011 征求意见结束 2011 Agreed by Quality Working Party May 2012 质量工作组通过 2012年5月 Adoption by CHMP 14 May 2012 CHMP采用 2012 Adoption by CVMP 14 June 2012 CVMP采用 2012 Date for coming into effect 30 June 2013 生效 2013 ? Keywords Antibiotics, specifications, related impurities 关键词 抗生素，质量标准，有关杂质 ? Guideline on setting specifications for related impurities in antibiotics 抗生素中有关杂质质量标准设定指南 Table of contents?目录 Executive summary 实施总结 1. Introduction (background) 1.?介绍 2. Scope 2.?范围 3. Legal basis 3．法规依据 4. General requirements 4.?通用要求 5. Impurity profiling and reporting, identification and qualification thresholds 5.?杂质谱和报告、鉴定和定性阈 5.1. Active substances manufactured by semi-synthesis 5.1.?半合成活性物质 5.2. Active substances manufactured by fermentation, single compound 5.2.?发酵单成份活性物质 5.3. Active substances manufactured by fermentation, family of compounds 5.3.?发酵多成份活性物质 5.4. Peptides manufactured by fermentation/semi-synthesis 5.4.?发酵/半合成肽 5.5. Active substances for veterinary use 5.5.?仅兽药活性物质 5.6. Special cases for very complex impurity profiles 5.6.?杂质谱复杂的特殊情况 6. New applications and variations 6.?新申报和变更 6.1. New active substances 6.1.?新活性物质 6.2. Existing active substances, not subject to a Ph. Eur. monograph 6.2.?已有活性物质，EP未收载 6.3. Active substances subject to a Ph. Eur. monograph 6.3. EP收载的活性物质 6.3.1. Existing active substances subject to a Ph. Eur. monograph with transparency statement and availability of a CRS for peak identification or relative retention t