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国家药品抽检的抽样流程管理研究 |
Process Management of National Drug Sampling and Inspection |
投稿时间:2020-05-17 修订日期:2020-07-11 |
DOI: |
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 current situation of national drug sampling and inspection, exploring methods of improving sampling efficacy. Methods: By sorting and analyzing possible risks of current processes, optimize process management of sampling, propose feasible countermeasures. Results and conclusions: Review the implementation of national drug sampling and inspection in recent years on the basis of current systems and job distribution, analyze returned samples. Using the concept of risk management, explore possible risks of laws and regulations, organization, infomation systems and conpliance. Optimize processes of sampling mailing, receiving and purchase by building up a tracking system. |
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