六西格玛质量改善模型在仿制药小试研究过程中的应用
投稿时间:2019-12-30  修订日期:2020-04-27  点此下载全文
引用本文:周娜,周清萍,梁毅.六西格玛质量改善模型在仿制药小试研究过程中的应用[J].药学实践杂志,2020,38(5):476~480
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作者单位E-mail
周娜 中国药科大学国际医药商学院江苏 南京 211198  
周清萍 中国药科大学国际医药商学院江苏 南京 211198  
梁毅 中国药科大学国际医药商学院江苏 南京 211198 3083318949@qq.com 
中文摘要:目的 为提高我国制药企业的仿制药小试研究水平,避免许多药企在研发过程中存在的缺陷,探究在小试过程中运用六西格玛质量改善模型(DMAIC)的可行性。方法 通过查阅文献和实例的方式,利用DMAIC模型,以某仿制原料药还原工艺为例,评估其实施效果。结果 DMAIC模型在该案例中得到成功运用。该模型有助于合理进行小试团队建设,帮助研发人员找到关键质量属性和关键工艺参数等,保证实验数据的真实性和完整性,可为后续工业生产提供宝贵经验并满足注册申报要求。结论 DMAIC模型可以有效解决诸如统筹安排差、与生产衔接不畅、管理不规范等问题,体现质量源于设计(QbD)的理念,对国内仿制药小试研究有良好的借鉴意义。
中文关键词:DMAIC模型  仿制药  小试研究
 
Application of six sigma quality improvement model in the laboratory research of generic drugs
Abstract:Objective To improve laboratory research of generic drugs in Chinese pharmaceutical enterprises, avoid the defects in the research process, and explore the feasibility of six sigma management (DMAIC) as improvement model in the process of generic drugs laboratory research.Methods The effectiveness of DMAIC implementation was evaluated through the literature search and case study of a generic API’s process with the DMAIC model.Results The DMAIC model was successfully applied in this case. The model made laboratory research more reasonable, helped R&D personnel to pinpoint key quality attributes and process parameters, etc., ensured the authenticity and completeness of experimental data, and provided valuable data for subsequent industrial production as well as meeting registration requirements.Conclusion DMAIC model can solve the problems, such as poor overall arrangement, poor connection with production, and irregular management. It embodied the idea of Quality by Design (QbD) and can be used as good reference for domestic laboratory research of generic drugs.
keywords:DMAIC model  generic drugs  laboratory research
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