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| 浅谈GLP实验室仪器设备SOP的制定 | |
| 引用本文： | 于志瀛,朱庆,王焱. 浅谈GLP实验室仪器设备SOP的制定[J]. 中国药事, 2010, 24(2): 144-146 |
| 作者姓名： | 于志瀛 朱庆 王焱 |
| 作者单位： | 1. 广东食品药品职业学院,广州,510520 2. 广州市医药工业研究所 3. 广东省食品药品职业技术学校 |
| 摘 要： | 目的为GLP实验室制定仪器设备的标准操作规程（SOP）提供参考。方法通过介绍仪器设备SOP具体问题的编写方法，提出SOP的制定程序，以提高设备SOP的实用性和可操作性。结果与结论SOP是过程控制的前提，是质量体系保证的基础。本文介绍的观点不仅对于安评机构适用，对于其它领域制定SOP同样适用。 |
| 关 键 词： | 仪器设备 标准操作规程 流程图 药物非临床研究质量管理规范 程序性文件 |
Discussion on Establishment of SOP for Instruments and Equipment in GLP Laboratory |
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| Yu Zhiying,Zhu Qing,Wang Yan. Discussion on Establishment of SOP for Instruments and Equipment in GLP Laboratory[J]. Chinese Pharmaceutical Affairs, 2010, 24(2): 144-146 | |
| Authors: | Yu Zhiying Zhu Qing Wang Yan |
| Affiliation: | Yu Zhiying,Zhu Qing1 , Wang Yan2(Guangdong Food , Drug Vocational College,Guangzhou 510520,1Guangzhou Institute of Pharmaceutical Industry,2Guangdong Food , Drug Vocational Technical School) |
| Abstract: | Objective It was a reference for GLP laboratory to develop standard operating procedures(SOP) of instruments and equipment.Methods Through presenting compilation method of specific issues of instruments and equipment SOP,and putting forward the formulation of SOP procedures to improve equipment SOP's practicality and maneuverability.Results and Conclusion SOP is a prerequisite for process control and is the basis of quality system assurance.This article describes the point of view not only for the safety ev... |
| Keywords: | instruments and equipment SOP flow diagram GLP procedural document |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |