基于FEMA的药品研发中试质量风险管理

FEMA Based Pilot-scale Quality Ris k Management in Drug Development

目的:探讨质量风险管理工具,在药品研发中试中的运用;方法:运用失效模式与影响分析(FEMA)进行风险管理,提出整体风险框架和应用过程中的思考,以固体制剂软胶囊应用为例,阐述管理方法和要点;结果:通过失效模式与影响分析的应用,减少了中试失败质量风险;结论:建立研发中试质量风险管理流程,可使制剂生产企业研发中试质量管理工作更规范有效,确保中试项目高效、高质量完成。

Objective: To explore the application of quality risk management tools in the pilot trial of drug R &D. Methods: Failure mode and impact analysis(FEMA) was used to carry out risk management, the overall risk framework and the thinking in the application process were put forward, and the management methods and key points were expounded with the application of soft capsules of solid preparations as an example. Results: Through the application of failure mode and impact analysis, the quality risk of pilot test failure was reduced. Conclusion: Establishing the quality risk management process of R&D pilot test can make the quality management of R&D pilot test more standardized and effective, and ensure that the pilot test project is completed efficiently and with high quality.