无菌控制生产过程质量控制策略探究  

Research on Quality Control Strategy of Aseptic Control Production Process

作　　者：陈青青 汪霄峰 陈王露 孙志勇 戴志芳 Chen Qing-qing;Wang Xiao-feng;Chen Wang-lu;Sun Zhi-yong;Dai Zhi-fang(Zhejiang Whidison Pharmaceutical Co.,Ltd.,Zhejiang Hangzhou 311400)

机构地区：[1]浙江惠迪森药业有限公司,浙江杭州311400

出　　处：《生物化工》2018年第2期109-111,120,共4页Biological Chemical Engineering

摘　　要：无菌控制生产技术要求严格,需要很好的质量控制措施。本文对无菌控制生产过程中质量控制的策略进行探究,主要从对生产工艺的监制方法,对生产设备的监测策略,对人员的监控策略,对材料的无菌监测策略,对无菌生产环境的监制策略几方面进行探讨。The aseptic control technology is strict and needs good quality control measures. This paper explores the strategy of quality control in the production process of aseptic control, mainly from the monitoring methods of the production process, the monitoring strategy of production equipment, the monitoring strategy of the personnel, the aseptic monitoring strategy of materials and the monitoring strategy of the aseptic production environment.

关 键 词：无菌生产 质量控制 无菌检验 策略 

分 类 号：R187[医药卫生—流行病学]