摘要
系统研究我国药品研制与生产阶段分级管理体系的构建方法、实施效果及优化策略,探索建立科学、高效的分级管理模式,为提升医药行业质量管理水平提供理论依据和实践参考。采用回顾性研究方法,收集2018—2023年300个药品研发项目和150家制药企业的管理实践数据。运用描述性统计、比较分析、多元回归等方法,分析不同分级管理模式的特点、实施效果及影响因素。结果显示,基于“创新度-复杂度-风险度”的研发项目分级模式和“产品特性-工艺要求-质量风险”的生产管理分级体系具有显著效果。分级管理的实施使研发周期平均缩短18.5%,质量相关偏差事件减少35.2%。多因素分析表明,分级标准的科学性(β=0.426,P<0.001)、执行的规范性(β=0.385,P<0.001)和支撑体系的完备性(β=0.352,P<0.001)是影响管理效果的主要因素。研究发现,科学的分级管理体系能够显著提升药品研发效率和质量管理水平。建议从完善评估标准、强化过程管控、优化资源配置等方面持续改进分级管理体系。
This study systematically investigates the construction methods,implementation effects,and optimization strategies of China’s graded management system for drug development and production stages,aiming to establish a scientific and efficient graded management model and provide theoretical basis and practical reference for improving the quality management level of the pharmaceutical industry.A retrospective research method was adopted to collect management practice data from 300 drug R&D projects and 150 pharmaceutical enterprises between 2018 and 2023.Descriptive statistics,comparative analysis,multiple regression and other methods were used to analyze the characteristics,implementation effects and influencing factors of different graded management models.The results showed that the R&D project grading model based on“innovation-complexity-risk”and the production management grading system based on“product characteristics-process requirementsquality risk”had significant effects.The implementation of graded management reduced the average R&D cycle by 18.5%and quality-related deviation events by 35.2%.Multivariate analysis showed that the scientificity of grading standards(β=0.426,P<0.001),the standardization of execution(β=0.385,P<0.001)and the completeness of the support system(β=0.352,P<0.001)were the main factors affecting management effectiveness.The study found that a scientific graded management system can significantly improve drug R&D efficiency and quality management level.It is recommended to continuously improve the graded management system by improving evaluation criteria,strengthening process control,and optimizing resource allocation.
作者
钟晨
Zhong Chen(Shanghai Zhaowei Pharmaceutical Technology Co.,Ltd.,Shanghai 200233)
出处
《科技与健康》
2025年第12期69-72,共4页
Technology and Health
关键词
药品研制
生产管理
分级管理
风险控制
drug development
production management
graded management
risk control
