质量风险管理在大容量注射液生产中的应用
Chinese Journal of New Drugs(2016)
Abstract
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.
MoreKey words
quality risk management,large volume injection,hazard analysis and critical control point,failure mode and effects analysis,preparation information management system
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