化药注射剂生产所用塑料组件系统相容性风险评估研究及案例分析  

Risk Assessment Model and Case Analysis for Compatibility Studies of Plastic Components and Systems Used for Chemical Injection Manufacturing

作　　者：王璐 胡延臣 WANG Lu;HU Yan-chen(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国药学杂志》2022年第10期857-861,共5页Chinese Pharmaceutical Journal

摘　　要：目的探讨化药注射剂生产中所用的塑料组件系统与药品相容性研究。方法本研究主要介绍了风险评估的原则、风险评估模型以及相关案例。结果与结论借助风险评估这个有效工具,研究者可以更加科学合理的设计和开展化药注射剂生产所用塑料组件系统的相容性研究。OBJECTIVE To discuss the compatibility between plastic components and systems used in injection production and drug products.METHODS This reserch mainly introduces the principles of risk assessment,risk assessment model and related cases.RESULTS AND CONCLUSION With the help of risk assessment as an effective tool,the applicants can design and carry out compatibility study of plastic components and systems used in the production of chemical injections in a more scientific and reasonable manner.

关 键 词：塑料组件系统 生产组件相容性 风险评估 化药注射剂 

分 类 号：R95[医药卫生—药学]