| 过程能力指数及在药品质量控制中的应用探讨 |
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| 引用本文： | 谭德讲,赵嘉,曹秀堂.过程能力指数及在药品质量控制中的应用探讨[J].中国药事,2014(11):1213-1218. |
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| 作者姓名： | 谭德讲 赵嘉 曹秀堂 |
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| 作者单位： | 中国食品药品检定研究院;浙江省食品药品检验研究院;中国人民解放军总医院 |
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| 基金项目： | 中国食品药品检定研究院学科带头人项目——统计学分析方法在药品检定中的应用研究(编号2011X3) |
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| 摘 要： | 目的将已在工业生产、公共服务等多个领域广泛应用的过程能力分析技术引入药品领域。方法对评价过程能力的三个已公认的基本指数进行简单的介绍,同时阐述其在相关领域的应用价值。结果理解了过程能力分析中的基本概念和理论,明确过程能力指数在药品质量控制中的应用及其重要作用。结论将过程能力指数作为一种重要的工具,将更好的实现对药品生产过程及产品质量的评估和监控。
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| 关 键 词： | 过程能力分析 过程能力指数 药品生产 质量控制 |
Process Capability Indexes and Their Applications in Pharmaceutical Quality Control |
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| Tan Dejiang;Zhao Jia;Cao Xiutang.Process Capability Indexes and Their Applications in Pharmaceutical Quality Control[J].Chinese Pharmaceutical Affairs,2014(11):1213-1218. |
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| Authors: | Tan Dejiang;Zhao Jia;Cao Xiutang |
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| Institution: | Tan Dejiang;Zhao Jia;Cao Xiutang;National Institutes for Food and Drug Control;Zhejiang Institute for Food and Drug Control;Chinese PLA General Hospital; |
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| Abstract: | Objective To introduce process capability Analysis,which has been widely used in many areas such as industrial production,public service etc.,into the pharmaceutical field.Methods The three basic indexes publically recognized in the evaluation of process capability were briefly introduced,and their application value in the related fields was elaborated.Results The basic concept and theory of process capability analysis were explained,and the application and important role in drug quality control were pointed out.Conclusion The process capability index can be used as an important tool to achieve better assessment and monitoring in the whole drug manufacturing and quality control in the future. |
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| Keywords: | process capability analysis process capability index pharmaceutical manufacturing quality control |
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