六西格玛质量改善模型在仿制药小试研究过程中的应用

Application of six sigma quality improvement model in the laboratory research of generic drugs

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。

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.