药品生产质量管理规范对疫苗生产无菌保障的研究  

Study on the Sterility Assurance of Vaccine Production Based on the Quality Management Practice of Drug Production

作　　者：平丽芬 朱毅 王亚芳 何顺权 郑力 杨红斌 杨磊 PING Lifen;ZHU Yi;WANG Yafang;HE Shunquan;ZHENG Li;YANG Hongbin;YANG Lei(Institute of medical biology Chinese academy of Medical sciences,Kunming 650000,China)

机构地区：[1]中国医学科学院医学生物学研究所,云南昆明650000

出　　处：《化工管理》2025年第5期14-18,共5页Chemical Management

摘　　要：由于药品生产质量管理规范对疫苗的无菌工艺贯穿了疫苗生产的全过程,在疫苗生产过程中的各个细节都是无菌生产工艺控制的重点。文章针对疫苗生产的无菌保障,结合现代疫苗生产中的应用与实践进行了详细的阐述,并根据药品生产质量管理规范,通过对人员、物料、生产设备、厂房设施、无菌工艺模拟等方面的无菌保障应用研究,结合在实际生产中的实践案例,从而为达到疫苗生产无菌保障的目的提供参考。Since the aseptic process of vaccine runs through the whole process of vaccine production,every detail in the vaccine production process is the focus of aseptic production process control.In this paper,the aseptic assurance of vaccine production is elaborated in detail in combination with the application and practice of modern vaccine production.According to the quality management standards of drug production,the application research of aseptic assurance in personnel,materials,production equipment,plant facilities,aseptic process simulation and other aspects is combined with practical cases in actual production.Thus,it can provide reference for the aseptic guarantee of vaccine production.

关 键 词：疫苗生产 质量管理 无菌工艺 无菌保障 医药化工 

分 类 号：TQ460.63[化学工程—制药化工]