药品补充检验方法管理质量与效率研究

On Management Quality and Efficiency of Drug Supplementary Testing Methods

目的:阐述如何应用标准管理模式和流程优化理论来改进药品补充检验方法管理质量与效率,评价改进效果。方法:梳理药品补充检验方法发展过程,对比药品补充检验方法管理思路和模式的变化;采用管理改进前后的数据比对,评价药品补充检验方法管理质量与效率的改进。结果与结论:出台药品补充检验方法管理工作规程和研制技术指南,建立信息化管理系统,优化管理流程,规范方法起草与复核。管理改进措施出台前后3年平均数据比对显示,申报方法中的批准比例在提高,方法审评审批用时在减少,证实管理质量和效率的提升。

Objective:To illustrate how standard management models and process-optimizing theory could be applied to improve the management quality and efficiency of drug Supplementary Testing Methods(STMs)and to evaluate the effectiveness of the improvements.Methods:The development process of STMs was combed to compare the changes in management thoughts and models of STMs.The improvement in management quality and efficiency of STMs was reviewed by comparing the data before and after adopting management improvements.Results and Conclusion:A protocol for the management of STMs and a technical guide for their development were introduced,an information management system was established,the management process was optimised,and the drafting and checking of methods were standardised.A comparison of the average data for the three years before and after the launch of the management improvement measures shows that the proportion of approvals in the submitted methods is increasing and the time consumed in application and approval is decreasing,which verifies the improvement in management quality and efficiency.