| 朱嘉亮,任春,胡骏,李哲媛,朱炯,杨悦.现行药品质量抽查检验模式下关于抽样工作的探析[J].中国药事,2020,34(9):1008-1015 |
| 现行药品质量抽查检验模式下关于抽样工作的探析 |
| Discussion and Analysis on Sampling Work under Current Drug Quality Sampling and Testing Mode |
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| DOI：10.16153/j.1002-7777.2020.09.003 |
| 中文关键词: 相互独立完全穷尽的分析法 药品 抽样 质量抽查检验 |
| 英文关键词: mutually exclusive collectively exhaustive analysis method drug sampling quality sampling and testing |
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| 中文摘要: |
| 目的：旨在通过对新修订《药品质量抽查检验管理办法》的分析和探讨，提出可行的应对举措和建议，推动药品抽检管理模式的创新。方法：结合药品抽检工作中的实际问题，应用相互独立完全穷尽的分析法，按照抽样的流程，分别从抽样前、抽样中、抽样后3个环节对《药品质量抽查检验管理办法》中与抽样相关的条款进行解析和讨论，就如何做好新时期的药品抽检抽样工作提出建议和对策。结果与结论：抽样作为药品抽检工作的重要组成部分，是做好药品抽检工作的起点。各级药品监管机构应该完善现有抽检工作模式，严格执行新修订的《药品质量抽查检验管理办法》中的药品抽样工作要求， 有效促进药品抽样工作的科学性、合法性、代表性。 |
| 英文摘要: |
| Objective: Through the analysis and discussion of the newly revised Regulations for Drug Quality Sampling and Testing, this paper puts forward feasible measures and suggestions to promote the innovation of drug sampling management model. Methods: Combined with the practical problems in the national drug random inspection, MECE analysis method was used according to the process of sampling, the terms related to sampling in the Regulations for Drug Quality Sampling and Testing were analyzed and discussed from three steps: before, during and after sampling, and suggestions and countermeasures were put forward on how to do the sampling of national drug sampling well in the new era. Results and Conclusion: Drug sampling is an important part of drug sampling and the starting point of drug work. Drug regulatory agencies at all levels should improve the existing sampling mode, strictly implement the requirements of drug sampling in the newly revised Regulations for Drug Quality Sampling and Testing, effectively promote the scientificity, legality, and representativeness of drug sampling. |
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