质量风险管理在大容量注射液生产中的应用  

Application of quality risk management in the production of large volume injections

作　　者：郑辉辉[1] 黄燕鹏[1] 王庆芬[1] 张荣[1] 

机构地区：[1]解放军第一七五医院,厦门大学附属东南医院,漳州363000

出　　处：《中国新药杂志》2016年第5期495-498,共4页Chinese Journal of New Drugs

摘　　要：通过分析大容量注射液的生产工艺流程,总结存在的质量风险因素,探讨质量风险管理在非PVC多层共挤膜软袋大容量注射液生产中物料管理和生产工艺管理中的应用,结合制剂信息管理系统,建立一套完整的质量风险管理制度,保障大容量注射液的生产安全。Through analysis of the production process of large volume injections,the existed quality risk factors were summarized. Discussion was made about the application of quality risk management in material management and production process management in the production of large volume injections with non-PVC multilayer film soft bags,combining with preparation information management system,to establish a complete quality risk management system and guarantee the production safety of large volume injections.

关 键 词：质量风险管理 大容量注射液 危害分析和关键控制点 失效模式与影响分析 制剂信息管理系统 

分 类 号：R95[医药卫生—药学]