Annex 15Qualification and Validation(附件15确认与验证)正式版中英文对照.pdf

上海万逸医药科技有限公司刘伟强译 Ref. Ares(2015)1380025 - 30/03/2015 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Medicinal Products – Quality, Safety and Efficacy Brussels, 30 March 2015 EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use 欧盟人用及兽用药品GMP指导原则 Annex 15: Qualification and Validation 附件15：确认与验证 Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. Status of the document: Revision 文件状态：修订 Reasons for changes: Since Annex 15 was published in 2001 the manufacturing and regulatory environment has changed significantly and an update is required to this Annex to reflect this changed environment. This revision to Annex 15 takes into account changes to other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology. 变更原因：附录15至2001年颁布以来，制造业和法规环境发生了显著变化，因此 需要更新附录以反应这些环境的变化，附录15的修订还考虑到了欧盟