欧盟gmp11-计算机系统(中英文对照).docxVIP

EUROPEAN COMMISSION 欧盟委员会 HEALTH AND CONSUMERS DIRECTORATE-GENERAL 卫生与消费者协会 Public Health and Risk Assessment 公共卫生与风险评估 Pharmaceuticals 药品 Brussels, SANCO/C8/AM/sl/ares(2010)1064599 EudraLex The Rules Governing Medicinal Products in the European Union 欧盟药品生产规范 Volume 4 卷4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use 人用与兽用药品良好生产管理规范 Annex 11: Computerised Systems 附件11：计算机系统 Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for humanuse and Article 51 of Directive 2001/82/EC o