摘要
马钢气体销售分公司2011年取得医用氧GMP证书后具备生产销售医用氧产品资格;2015年按国家相关法律法规的要求完成了新版医用氧GMP证书的认证,同时实现了医用氧产品的销售。结合新版GMP认证过程流程,介绍了马钢气体销售分公司在医用氧生产、质量管理方面的实践经验。
MaSteel Gas Sales Company has been qualified to produce medical oxygensince it obtained the GMP certification of medical oxygen in 2011. The company got thenew-edition GMP certification according to the requirement of related national regulation in2015 and realized sale of medical oxygen at the same time. The paper introduces the practiceexperience of MaSteel Gas Sales Company in production and quality management of medicaloxygen in the light of the approval process of the new-edition GMP certification.
作者
陈旭
卢德云
袁苑
蒋小林
CHEN Xiu;LU Deyun;YUAN Yuan;JIANG Xiaolin(Gas Sales Company of Maanshan Iron & Steel Co., Ltd., Maanshan, Anhui 243011, China)
出处
《冶金动力》
2016年第10期61-64,共4页
Metallurgical Power
关键词
医用氧
药品
生产质量管理
medical oxygen
medicine
production quality management