《中华人民共和国药品管理法》及《医疗机构制剂配制质量管理规范》的实施 (以下简称《药品法》、《质量管理规范》) ,对医院制剂的质量要求更高、管理更规范。对医院制剂的生产条件、生产制度、产品质量等的管理逐步趋向于药品生产企业样管理。我市医院中药制剂近几年发展很快 The implementation of the “Pharmaceutical Administration Law of the People’s Republic of China” and “Standards for the Quality Control of Preparations for Preparation of Medical Institutions” (hereinafter referred to as the “Pharmaceutical Law” and “Quality Management Practice”) require higher quality and more standardized management of hospital preparations. The management of production conditions, production systems, and product quality of hospital preparations tends to be gradually managed by pharmaceutical manufacturers. The development of traditional Chinese medicine preparations in our hospital has developed rapidly in recent years