原料药生产工艺工业化考虑

Consideration on Industrialization of API Manufacturing Process

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.