摘要
由于药品被广泛应用于临床治疗,药品质量直接影响患者治疗效果,因此,药品质量的监督和管理极为重要。无菌药品是一项较为严格的制药项目,基于质量意识觉醒角度,社会对其质量要求更为严苛,要求其必须严格执行GMP的相关规定,为实现无菌药品企业在获取GMP认证后,加强生产现场的质量管理,本文对其管理技术、要求和内容进行探讨。
As drugs are widely used in clinical treatment,drug quality directly affects the treatment of patients,therefore,the supervision and management of drug quality is very important.Aseptic drugs is a relatively strict pharmaceutical project.Based on the awakening of quality consciousness,the society demands its quality more strictly,and it is required to strictly implement the relevant provisions of GMP.In order to realize the Aseptic Drug Enterprises After obtaining GMP certification,to strengthen the quality management of the production site,this paper discusses its management technology,requirements and content.
作者
王校生
Wang Xiaosheng(Zhejiang Jianfeng Pharmaceutical Co.,Ltd.,Zhejiang,321000)
出处
《当代化工研究》
2021年第10期170-171,共2页
Modern Chemical Research
关键词
无菌药品
GMP认证
生产现场
质量管理
sterile drugs
GMP certification
production site
quality management
