药品生产偏差产生原因及处理浅析  

Analysis of Causes and Treatment of Drug Production Deviations

作　　者：曹怀宝[1] CAO Huai-bao(Changzhou Vocational Institute of Textile and Garment,Jiangsu Changzhou 213164,China)

机构地区：[1]常州纺织服装职业技术学院,江苏常州213164

出　　处：《广州化工》2021年第24期202-204,共3页GuangZhou Chemical Industry

摘　　要：药品质量是关系人们生命健康的大事。药品生产对药品质量有着直接影响,生产过程不可避免地会出现偏差。偏差一般包括在药品生产、检验、管理过程中发生的不符合已批准标准或规定所产生的各种偏差,我国对此也有明确规定。药品GMP认证是国家对药品生产企业监督检查的一种有效手段,是对药品生产企业(车间)实施GMP情况检查的认可过程。认为要树立企业对偏差管理的正确意识,加强偏差管理培训并建立科学的偏差管理程序。The quality of pharmaceuticals is an important issue for people s lives and health.Drug production has a direct impact on the quality of drugs,the production process will inevitably deviations.Deviations generally include those that occur during the production,inspection and management of drugs that do not meet the approved standards or regulations,which are also clearly defined in China.GMP certification is an effective means of national supervision and inspection of drug manufacturing enterprises,and is an approved process to check the implementation of GMP in drug manufacturing enterprises(workshops).We believe that we need to establish a proper awareness of deviation management,strengthen training on deviation management and establish scientific deviation management procedures.

关 键 词：药品生产 偏差 原因 GMP认证 药品质量 

分 类 号：TQ460.8[化学工程—制药化工]