化学药物制剂工业化研发质量体系及管理实践

The Quality System and Management Practice of the Industrialized Research and Development of Chemical Pharmaceutical Preparations

化学药物制剂工业化研究与开发在药品研发中至关重要,具有多学科协同、技术难度大、周期长、投入资金多的特点。因此,建立与化学药物制剂工业化相适应的质量管理体系和方法,对项目的推进和成功具有重要作用。

The industrialized research and development of chemical pharmaceutical preparations is very important in the research and development of pharmaceuticals.It has the characteristics of multidisciplinary collaboration,technical difficulty,long cycle,and large investment funds.Therefore,the establishment of a quality management system and method compatible with the industrialization of chemical pharmaceutical preparations plays an important role in the promotion and success of the project.