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.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第5期495-498,共4页
Chinese Journal of New Drugs
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
quality risk management
large volume injection
hazard analysis and critical control point
failure mode and effects analysis
preparation information management system
