新建原料药GMP生产线的设计问题探讨

Discussion about Design of New API GMP Production Line

目的为新建原料药GMP生产线提供参考。方法分析原料药GMP生产线的特点,对新建原料药GMP生产线需注意的问题进行探讨。结果与结论原料药的生产工艺过程较为复杂,新建原料药GMP生产线应考虑的问题很多,必须进行细致的分析和研究,才能使设计符合GMP的要求。

Objective To provide reference for the establishment of new API GMP production line. Methods The features of API GMP production line were analyzed, and the question of new API GMP production line were discussed. Results and Conclusion The raw material drug production process was very complicated, and many issues should be considered in establishment of API GMP production line. New API production line must be analyzed and researched carefully to make the design comply with GMP requirements.