贵州省医用氧生产企业规范化生产存在问题探析  

Analysis of the problems in standardized production of medical oxygen production enterprises in Guizhou Province

作　　者：周明皓 张红曼 ZHOU Minghao;ZHANG Hongman(Center for Drug Inspection of Guizhou Medical Products Administration,Guizhou 550081,China)

机构地区：[1]贵州省药品监督管理局检查中心,贵州贵阳550081

出　　处：《医用气体工程》2025年第1期20-23,共4页Medical Gases Engineering

摘　　要：目的:回顾近两年贵州省医用氧生产企业执行《药品生产质量管理规范》(2010年修订)(简称GMP)的情况及存在的主要问题,探索医用氧生产企业合规生产的新模式及监管部门科学监管的新方法。方法:通过对近两年省内的11家医用氧生产企业的药品生产现场检查情况进行汇总分析,根据其存在问题作出建议。结果:省内医用氧生产企业近两年在执行GMP的医用氧附录、质量控制与质量保证、文件管理、设备、机构与人员与生产管理等方面仍需要进一步改善。结论:建议企业根据实际问题采取有效的纠正与预防措施;监管部门应采用前瞻或回顾的方式对医用氧生产企业进行科学监管,以确保已上市医用氧产品的安全性与合规性。Objective:To review the implementation of the Good ManufacturingPractice(GMP)revised in 2010 by medical oxygen production enterprises in Guizhou Province in the past two years and the main existing problems,and to explore new models for compliant production of medical oxygen production enterprises and new methods for scientific supervision by regulatory authorities.Methods:By summarizing and analyzing the on-site inspections of drug production in 11 medical oxygen production enterprises in the province in the past two years,recommendations were made based on the existing problems.Results:Medical oxygen production enterprises in the province still needed further improvement in implementing GMP medical oxygen appendices,quality control and assurance,document management,equipment,institutions and personnel,and production management in the past two years.Conclusion:It is recommended that enterprises take effective corrective and preventive measures based on actual problems.In addition,regulatory authorities should adopt a forward-looking or retrospective approach to scientifically supervise medical oxygen production enterprises to ensure the safety and compliance of medical oxygen products already on the market.

关 键 词：医用氧 《药品生产质量管理规范》 存在问题 前瞻与回顾 科学监管 

分 类 号：TQ116[化学工程—无机化工]