药品技术转移过程中工程和设备方面的几点思考

Several Issues in Engineering and Equipment for Drug Technology Transfer Process

当前制药行业环境中,很多情况下均会涉及药品技术转移活动,如新药开发到商业化生产的良好过渡,企业建造新生产基地,集团并购、CRO/CMO/CDMO外包活动等。药品技术转移涉及了工艺、分析方法、文件、物料、工程和设备等关键要素,将针对药品技术转移过程中工程和设备方面需要考虑的项目进行分析说明。

In current pharmaceutical industry,drug technology transfer will be involved in many cases,such as the transition from new drug development to commercial production,construction of new production bases,group mergers&acquisitions,and CRO/CMO/CDMO outsourcing activities.The drug technology transfer involves key elements such as processes,analytical methods,documents,materials,engineering and equipment.In this paper,the items to be considered as respect to engineering and equipment in the process of drug technology transfer were analyzed and explained.