探讨GCP药房建设与发展之路  

Exploring the road to GCP pharmacy construction and development

作　　者：王佳庆[1] 徐春敏[1] 王维聪 WANG Jia-qing;XU Chun-min;WANG Wei-cong(Beijing Tiantan Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京天坛医院临床试验中心

出　　处：《中国新药杂志》2019年第24期3001-3003,共3页Chinese Journal of New Drugs

摘　　要：目的:探讨我院建立药物临床试验质量管理规范药房(GCP药房)的雏形及方法。方法:分别从空间条件及硬件设施、人员、建立标准操作规程及规章制度、全流程管理方式及制定药房管理预算等方面实现集中化管理试验药物。结果:GCP药房药品管理有序规范,药师专业能力有所提高。结论:建立GCP药房是提高药物临床试验质量的有效方法。Objective:To explore the prototype and methods of establishing good clinical practice(GCP)pharmacy in our hospital.Methods:Centralized management of test drugs was realized from the aspects of space conditions and hardware facilities,personnel,establishment of standard operating procedures and rules and regulations,whole process management methods and formulation of pharmacy management budget.Results:The drug management of GCP pharmacy was standardized and the professional ability of pharmacists was improved.Conclusion:Establishing a GCP pharmacy is an effective way to improve the quality of clinical trials.

关 键 词：药物临床试验 GCP药房 药师 

分 类 号：R969.4[医药卫生—药理学]