| 体外诊断试剂质量管理体系考核现场检查的程序和方法 |
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| 引用本文： | 田少雷. 体外诊断试剂质量管理体系考核现场检查的程序和方法[J]. 中国医疗器械杂志, 2010, 34(2): 129-132 |
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| 作者姓名： | 田少雷 |
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| 作者单位： | 国家食品药品监督管理局药品认证管理中心,北京,100061 |
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| 摘 要： | 介绍了体外诊断试剂质量管理体系考核现场检查的程序和方法．对要点和注意事项进行了探讨．旨在提高检查员的现场检查经验．保证体系考核工作的质量、规范和高效。
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| 关 键 词： | 体外诊断试剂 质量管理体系 现场检查 程序 方法 |
Site Inspection Procedures and Methods for Evaluation of the Quality Management System of In vitro Diagnostic Regents |
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| Tian Shaolei Center for Drug Certification,State Food , drug administration,Beijing. Site Inspection Procedures and Methods for Evaluation of the Quality Management System of In vitro Diagnostic Regents[J]. Chinese journal of medical instrumentation, 2010, 34(2): 129-132 |
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| Authors: | Tian Shaolei Center for Drug Certification State Food drug administration Beijing |
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| Affiliation: | Tian Shaolei Center for Drug Certification,State Food , drug administration,Beijing 100061 |
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| Abstract: | In this paper,the procedures,logos,methods,essentials as well as notable problems for inspecting the qualification management system of in vitro diagnostic regent manufactures are discussed,with aims of promoting inspector's practical level and consequentially ensuring the quality,standard and eficacy of the inspection. |
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| Keywords: | in vitro diagnostic regent qualification management system site inspection procedures methods |
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