解读新版GMP对原料药工艺设备的要求

摘要

对典型的原料药设备进行了详细的阐述，并结合新版GMP对无菌原料药工艺设备的特殊要求，为原料药设备的设计、选型提供了借鉴。%From the respects of summary of key process equipment, production design of the way to meet the requirement in 2010 edition GMP in the production of API was discussed in this article.