医用氧委托生产资质办理与管理流程及重点  

Process and key points of qualification management in medical oxygen commissioned production

作　　者：李晓 马海龙 LI Xiao;MA Hailong(Beijing Shougang Gas Co.,Ltd.,Beijing 101304,China)

机构地区：[1]北京首钢气体有限公司,北京101304

出　　处：《医用气体工程》2024年第4期10-11,36,共3页Medical Gases Engineering

摘　　要：随着医疗机构的不断扩大,医用氧的需求日益增加。医用氧委托生产模式的优势日益突显,在药品监督管理局的批准下,可以合法合规地办理医用氧委托生产资质,实现解决医用氧供应保障和企业发展的共赢。医用氧委托生产资质办理和委托生产管理应完善委托双方管理、避免管理漏洞成为管理的关键。应加强委托生产管理、质量协议约定责任和驻厂监督员监督检查,为医用氧上市放行提供保证。With the continuous expansion of medical institutions,the demand for medical oxygen is increasing,and the advantages of medical oxygen commissioned production mode are becoming increasingly prominent.With the approval of the National Medical Products Administration,medical oxygen commissioned production qualification can be legally and lawfully handled to achieve the win-win situation of medical oxygen supply security and enterprise development.Medical oxygen commissioned production qualification management and commissioned production management should improve the management of both entrusted parties to avoid management loopholes,which has become the key to management.It is necessary to strengthen the management of entrusted production,the responsibility stipulated in the quality agreement,and the supervision and inspection of resident supervisors,so as to provide guarantee for the release of medical oxygen on the market.

关 键 词：医用氧 委托 资质办理 管理 

分 类 号：TQ116[化学工程—无机化工]