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药品质量标准执行过程中的几个关注点
引用本文:李婕,袁松,张红,黄海伟,林兰. 药品质量标准执行过程中的几个关注点[J]. 中国药事, 2017, 31(2): 170-173
作者姓名:李婕  袁松  张红  黄海伟  林兰
作者单位:中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050
摘    要:目的:分析药品质量标准执行时遇到的典型问题,思考药品检验人员如何践行“科学检验精神”,从而保证检验结果的准确、可靠。方法:从药品质量标准中的判定细则、语言理解、样品制备及补充检验方法四个方面,对药品检验人员提出执行建议。结果与结论:药品检验人员要熟练掌握专业技术,尊重科学规律,同时具有追求和证实客观事实的责任心,才能真正发挥药品质量标准的作用,从而保证人民群众用药安全。

关 键 词:药品质量  质量标准  药品检验  科学检验  检验结果
收稿时间:2016-11-03

On Implementation of Drug Quality Standards
Li Jie,Yuan Song,Zhang Hong,Huang Haiwei and Lin Lan. On Implementation of Drug Quality Standards[J]. Chinese Pharmaceutical Affairs, 2017, 31(2): 170-173
Authors:Li Jie  Yuan Song  Zhang Hong  Huang Haiwei  Lin Lan
Affiliation:National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China and National Institutes for Food and Drug Control, Beijing 100050, China
Abstract:Objective: To analyze typical problems in implementing drug quality standards, guide the analysts to consider how to realize the spirits of scientifc testing, so as to ensure the accuracy and reliability of testing results.Methods: Suggestions were given to the drug analysts from the aspect of drug quality standards including decision rules, language understanding, sample preparation and supplementary testing methods.Results and Conclusion: Analysts should respect the laws of science, master the professional skills, develop the sense of responsibility to confrm the objective facts, in order to fully exert the effects of drug quality standards, so as to ensure the drug safety.
Keywords:drug quality   quality standards   drug testing   scientifc testing   testing results
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