药品生产企业氮气系统管理  

Management of nitrogen system in pharmaceutical enterprises

作　　者：沈海宾 SHEN Haibin(Shanghai Fudan Forward Pharmaceutical Co.,Ltd.,Shanghai 201111,China)

机构地区：[1]上海复旦复华药业有限公司,上海201111

出　　处：《上海医药》2018年第21期66-68,共3页Shanghai Medical & Pharmaceutical Journal

摘　　要：氮气作为制药企业重要的生产用气之一,与产品直接接触,但是在药品生产管理中往往没有得到重视。文章通过对氮气的特点及分类、GMP对于氮气系统的要求、氮气系统的确认、氮气系统的日常监控、氮气供应商管理维护等方面阐述药品生产企业氮气管理的全过程,明确了药品生产企业管理氮气系统的方法及需要注意的问题。Nitrogen as one of the most important gases for pharmaceutical production, is directly contacted with products, but great attention has not been paid in its management. The whole process of nitrogen management in pharmaceutical enterprises was expounded from various aspects including the characteristics and classification of nitrogen, the requirements of GMP for nitrogen system, the confirmation of nitrogen system, the daily monitoring of nitrogen system, the management and maintenance of nitrogen suppliers and so on, and the methods and problems needing attention in the management of nitrogen system in pharmaceutical enterprises were also clarified.

关 键 词：氮气 验证 监控 供应商管理 

分 类 号：R951[医药卫生—药学]