GCP药房试验药品管理模式介绍

Introduction to the management mode of clinical trial drugs in GCP pharmacy

目的:介绍海口市人民医院的试验药品管理模式,以提升药物临床试验管理水平,保证临床试验质量。方法:根据《药物临床试验质量管理规范》(GCP)的要求并结合本院实际情况,建立GCP药房管理体系,包括药房文件管理、设备管理、药物管理人员资质,以及试验药品的接收、保管、发放、回收及留样等标准操作规程,总结存在的问题,并提出改进措施及建议。结果和结论:本院GCP药房试验药品的管理体系健全,标准操作规程可操作性强,基本满足各类临床试验的需求。药师在临床试验全过程发挥积极主动作用,保障受试者安全及试验质量。

Objective：To introduce the management mode of experimental drugs in People＇s Hospital of Haikou City,improve the management level,and ensure the quality of clinical trials.Methods：A management system of GCP pharmacy,including pharmacy document management,equipment management,drug administrator qualification,and standard operating procedures for the receipt,storage,distribution,recovery and retention of experimental drugs was established according to the GCP requirements and the actual conditions of the hospital.The problems that existed in management were summarized,countermeasures and suggestions for improvement were proposed.Results and Conclusion：The hospital has established a good management system for testing drugs in the GCP pharmacy.The standard operating procedures are highly practical and basically meet the needs of various clinical trials.The pharmacists play an active role in the whole course of clinical trials,so that they can guarantee the safety and quality of clinical trials.