摘要
本文论述了原料药生产工艺工业化应考虑的六个方面,有效引导药物研发工作者在工艺开发前期应关注因素,预测和判断放大生产前存在技术、安全、操作等风险,从而针对性的开展生产放大可行性研究,有效规避生产偏差发生,最大限度降低财产损失,保障我国原料药生产规模化运营。
This paper discusses six aspects that should be considered in the industrialization of API manufacturing process.It effectively guides the drug R&D workers to pay attention to the factors in the early stage of process development,and predict and judge technology,safety,operational and other risks before scaling up the manufacturing,so as to conduct scale-up feasibility studies,prevent deviations and minimize property losses to ensure the large-scale API manufacturing in China.
作者
戚郜飞
徐士伟
金爱民
张春红
Qi Gaofei;Xu Shiwei;Jin Aimin;Zhang Chunhong(Hansoh Pharmaceutical Co.,Ltd.,Lianyungang222000,China)
出处
《山东化工》
CAS
2020年第17期132-133,共2页
Shandong Chemical Industry
关键词
生产工艺
工业化
放大可行性研究
manufacturing process
industrialization
feasibility studies