摘要
质量风险管理是一种科学的管理方法,常用于药品生产和质量管理过程。药品共线生产是指药品在某些工艺步骤,与其他药品共用生产设施设备进行生产的方式。由于药品共线生产的特殊性,可能会对药品质量带来潜在风险,在本文中笔者对质量风险管理在药品共线生产时的应用进行了深入研究,对当前研究现状进行深入分析,以得出更加权威的结论。
Quality risk management is a scientific management method,which is often used in the process of drug production and quality management.Drug Share-line production refers to the way in which drug is manufactured in a certain process,share facilities and equipments with other drugs.Because of the particular method of Drug Shareline production,it may bring potential risks to drug quality.This paper aims to discuss the application and research progress of Quality risk management in Drug Share-line production,and try to give an authoritative conclusion.
作者
周玉柏
牛志彬
ZHOU Yu-bai;NIU Zhi-bin(Beijing University of Technology,Beijing 100124;Sinovac Biotech,ltd,Beijing 100085)
出处
《智慧健康》
2019年第11期59-61,共3页
Smart Healthcare
关键词
质量风险管理
共线生产
风险评估
Quality risk management
Share-line production
Risk assessment