| 质量管理在药品抽样中的应用 |
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| 引用本文： | 鲁军,张敏,庄子瑜,牛玉娟.质量管理在药品抽样中的应用[J].中国药事,2017,31(9):1052-1055. |
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| 作者姓名： | 鲁军 张敏 庄子瑜 牛玉娟 |
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| 作者单位： | 大连市药品检验所, 大连 116021,大连市药品检验所, 大连 116021,大连市药品检验所, 大连 116021,大连市药品检验所, 大连 116021 |
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| 摘 要： | 目的：建立药品抽样控制程序，对抽样行为进行有效控制。方法：根据CNAS-CL01《检测和校准实验室能力认可准则》条款5.7抽样、5.8检测和校准物品（样品）的处置规定，建立药品抽样控制程序。结果与结论：按照本抽样控制程序，可以实现规范抽样、运输、传递全过程的闭环控制，保证抽样的科学性、代表性、真实性，为检验工作提供合法的样品，确保检验结果的有效性。
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| 关 键 词： | 药品安全 质量管理 抽样控制程序 规范 追溯 |
| 收稿时间： | 2017/3/23 0:00:00 |
Application of Quality Management in Drug Sampling |
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| Lu Jun,Zhang Min,Zhuang Ziyu and Niu Yujuan.Application of Quality Management in Drug Sampling[J].Chinese Pharmaceutical Affairs,2017,31(9):1052-1055. |
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| Authors: | Lu Jun Zhang Min Zhuang Ziyu and Niu Yujuan |
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| Institution: | Dalian Institute for Drug Control, Dalian 116021, China,Dalian Institute for Drug Control, Dalian 116021, China,Dalian Institute for Drug Control, Dalian 116021, China and Dalian Institute for Drug Control, Dalian 116021, China |
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| Abstract: | Objective:To establish control procedure for drug sampling to effectively control the sampling. Methods:The control procedure for drug sampling was established according to clause 5.7 sampling, clause 5.8 testing and calibration items (sample) disposal of CNAS-CL01 sampling testing and calibration laboratory accreditation standard. Results and Conclusion:The closed loop control of the whole process, such as standard sampling, transportation, transfer could be realized in accordance with the control procedure for drug sampling so as to ensure the standard sampling scientificity, representativeness and authenticity to provide legal samples for inspection and to ensure the inspection results effectiveness. |
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| Keywords: | drug safety quality management control procedure for sampling standard trace |
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