摘要
现代药品冻干生产的质量控制模式,正从"检验决定质量"向"质量源于设计"模式发展。"过程分析技术"是实施"质量源于设计"理念的有效工具,本文综述了药品冻干"过程分析技术"新进展,对应用于药品冻干工艺开发及生产过程中的"过程分析技术"原理和特点进行了分析,这些过程分析新技术,能够对冻干过程关键参数进行实时监控,保证工艺输出质量,带来药品冷冻干燥技术创新。
In freeze-drying production, the mode of controlling pharmaceutical quality has been developed from ＂Quality by Test＂ to ＂Quality by Design＂. ＂ Process Analytical Technology＂ is the key tools which can help implement the core philosophy of ＂Quality by Design＂. Several novel process analytical technologies which are applied to the pharmaceutical freeze-drying industry are summarized ＇and analyzed. Several novel process analytical technologies which are applied to the pharmaceutical freeze-drying industry are summarized and analyzed. It is emphasized that the process analytical technologies will be joint utilized monitoring critical process parameters during freeze-drying processing to ensure the quality of process outputs.
出处
《流体机械》
CSCD
北大核心
2014年第6期75-79,共5页
Fluid Machinery
基金
上海市农业成果转化项目(113919N0400)
上海市农业成果转化项目(113919N0400)
上海市联盟计划项目(LM201364)
关键词
冷冻干燥
过程分析技术
质量源于设计
freeze-drying
process analytical technology
quality by design
