医院中药制剂质量保证体系的建立

Establishment of Quality Assurance System in Preparations of Traditional Chinese Medicines in Hospital

根据医疗机构中药制剂现状及医疗机构制剂配制质量管理规范,结合国家产业政策,阐述了建立中药制剂质量保障体系的重要性,并分别从文件管理、配制管理、质量管理、物料管理、使用管理、机构与人员管理、验证管理等方面简述建立医院中药制剂质量保证体系的方法,为提高中药制剂质量提供参考。

This paper expatiates the importance of quality assurance system in preparations of Traditional Chinese Medicines according to the current status of the preparations in medical institutions and Good Preparation Praetice（GPP） and sketches the method of quality assurance system in preparations of Traditional Chinese Medicine in hospital according to Doc- uments Control, preparation, quality, materials, utilization, organization, personnel and verification etc., to provide reference for improving the quality of the preparations of traditional Chinese medicine.