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新版GMP规范下无菌制剂洗烘灌封联动分装线URS

Distributing Packaging Line Conformed with New GMP and Integrated with Functions of Cleaning,Stoving,Filling and Packaging

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【作者】 史云赵兴平

【Author】 Shi Yun,Zhao Xingping(Research Institute of Medical Biology,China Academy of Medical Science,Kunming,650118)

【机构】 中国医学科学院医学生物学研究所

【摘要】 URS是设备采购的重要技术资料,针对新版GMP规范要求,结合洗烘灌封联动分装线系统及无菌制药工艺特点制定相关URS。

【Abstract】 User Requirement Specification(URS) is important technical information for equipment procurement.With respect to the requirements in new GMP and combined with the features of integration system with functions of washing,sterilizing,filling and packaging and aseptic process,in this article,the relevant URS was established.

  • 【文献出处】 医药工程设计 ,Pharmaceutical & Engineering Design , 编辑部邮箱 ,2013年02期
  • 【分类号】R95
  • 【下载频次】277
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