| 周悦鹏,李玥琦,王翀,朱嘉亮,邢以文.国家药品抽检工作中抽样流程管理研究[J].中国药事,2020,34(10):1124-1129 |
| 国家药品抽检工作中抽样流程管理研究 |
| Research on the Sampling Process Management of National Drug Sampling and Inspection |
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| DOI：10.16153/j.1002-7777.2020.10.002 |
| 中文关键词: 国家药品抽检 流程管理 风险管理 |
| 英文关键词: national drug sampling and inspection process management risk management |
| 基金项目: |
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| 中文摘要: |
| 目的：分析国家药品抽检工作中抽样流程的现状，探寻提高抽样工作效能的方法。方法：通过梳理、分析现行国家药品抽检抽样流程各环节风险，优化抽样流程管理思路，探讨可行的管理措施，并提出优化建议。结果与结论：在梳理国家药品抽检的组织体系和职责分工的基础上，回顾近年抽样执行情况，对退样情况进行分析。同时，结合风险管理理念，从法律法规、组织系统、信息系统、抽样合规性等方面探讨存在的风险，通过建立以样品为核心的追踪体系，对抽样、寄样、收样、购样环节进行流程管理并优化。 |
| 英文摘要: |
| Objective: To analyze the current situation of national drug sampling and inspection, and to explore methods of improving sampling efficacy. Methods: By sorting and analyzing possible risks of current national drug sampling and inspection processes, optimize the management ideas of sampling process, discuss feasible management measures and put forward optimization suggestions. Results and conclusions: On the basis of sorting out the organization system and division of responsibilities of the national drug sampling inspection, the implementation of sampling was reviewed in recent years and the situation of the returned samples was analyzed. In the meanwhile, combined with the concept of risk management, the existing risks in terms of laws, regulations, organizational system, infomation systems and sampling conpliance, etc were explored. Therefore, the process management was performed and optimized by establishing a tracking system with a core of samples from the aspects of sampling, sending samples, receiving samples. |
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