EMA最新溶残.docx

EMA残留溶剂指南附录???20 February 2013CPMP/QWP/450/03 -Rev.1, EMEA/CVMP/511/03 -Rev.1Committee for medicinal products for human use (CHMP)Committee for medicinal products for veterinary use (CVMP)Annexes to:CPMP/ICH/283/95 Impurities: Guideline for residual solvents CVMP/VICH/502/99 Guideline on impurities: residual solventsCPMP/ICH/283/95杂质：残留溶剂指南CVMP/VICH/502/99杂质指南：残留溶剂附录?Annex I: specifications for class 1 and class 2 residual solvents in active substances附录I：活性物质中1类和2类残留溶剂质量标准Annex II: residues of solvents used in the manufacture of finished products附录II：制剂生产中使用的溶剂残留Discussion at Quality Working PartyJanuary 2003 to June 2004Adoption by CVMPJuly 2004Adoption by CHMPJuly 2004Date for coming into operationJanuary 2005Rev.01 Adoption by Quality Working Party22 November 2012Rev.01 Adoption by CVMP7 February 2013Rev.01 Adoption by CHMP11 February 2013Rev.01 Date for coming into operation1 March 2013?质量工作组讨论2003年1月至2004年6月CVMP采纳2004年7月CHMP采纳2004年7月生效时间2005年1月质量工作组采纳版本012012年11月22日CVMP采纳版本012013年2月7日CHMP采纳版本012013年2月11日版本01生效日期2013年3月1日Annexes to: CPMP/ICH/283/95 Impurities: Guideline for residual solvents CVMP/VICH/502/99 Guideline on impurities: residual solventsCPMP/ICH/283/95杂质：残留溶剂指南CVMP/VICH/502/99杂质指南：残留溶剂附录Introduction?概述The two (V)ICH residual solvents guidelines, ICH Q3C Impurities: Guideline for residual solvents (CPMP/ICH/283/95) and VICH GL18 Guideline on impurities: residual solvents in new veterinary medicinal products, active substances and excipients (CVMP/VICH/502/99), have been in operation for several years, since March 1998 and June 2001 respectively.两份（V）ICH的残留溶剂指南：ICH Q3C杂质：残留溶剂指南（CPMP/ICH/283/95）和VICH GL18：杂质指南：新兽药制剂、活性成分和辅料中的残留溶剂（CVMP/VICH/502/99）已经分别自1998年3月和2001年6月开始使用多年了。However, it has become evident that further clarification was required regarding the specifications for Class 1 and class 2 residual solvents in active substances.但是，现在要求对活性物质中1类和2类残留溶剂的质量标准需要进行进一步的澄清。A clear interpretation of the issues regarding residues of solvents used in the