三阶段质量管理在药物研发中的应用  

Application of Three-stage Quality Management in Drug Development

作　　者：万平安 田丽娟[1] WAN Pingan;TIAN Lijuan(Shenyang Pharmaceutical University,Shenyang 110016,China;Moon(Guangzhou)Biotech Co.,Ltd.,Guangzhou 510530,China)

机构地区：[1]沈阳药科大学,辽宁沈阳110016 [2]慕恩(广州)生物科技有限公司,广东广州510530

出　　处：《化工管理》2024年第14期29-32,共4页Chemical Engineering Management

摘　　要：文章对比分析了二阶段质量管理与四阶段质量管理的局限性,研究三阶段质量管理的优越性,并以某微生态活菌制药企业在非临床研究模块实施三阶段质量管理的情况作为实践案例进行分析。该企业实施三阶段质量管理后方案偏离率从60%降至25%。通过问卷调研,结果显示有70.59%的员工认为三阶段质量管理对自身工作有较大的促进作用,实施三阶段质量管理达到了良好的效果。基于此,文章分析三阶段质量管理在制药企业质量管理中的可行性应用,为制药企业提升研发质量管理水平提供参考。This paper compares and analyzes the limitations of two-stage quality management and four-stage quality management,studies the advantages of three-stage quality management,and takes the implementation of three-stage quality management in non-clinical research module of a micro-ecological viable bacteria pharmaceutical company as a practical case.After the implementation of the three-stage quality management,the deviation rate of the scheme decreased from 60%to 25%.Through the questionnaire survey,the results show that 70.59%of employees believe that the three-stage quality management has a greater role in promoting their own work,and the implementation of the three-stage quality management has achieved good results.Based on this,this paper analyzes the feasibility and application of three-stage quality management in the quality management of pharmaceutical enterprises,and provides reference for pharmaceutical enterprises to improve the quality management level of R&D.

关 键 词：制药企业 药品研发 三阶段质量管理 风险管理 

分 类 号：R95[医药卫生—药学]