卫星药房建设提升临床试验质量

Construction of Satellite Pharmacy for Promotion of the Quality of Clinical Trial

试验用药品规范化管理有助于提升临床药物研究水平。从硬件设施、人员配备及资质、文件管理、质量控制等方面建设卫星药房,并采取GCP药房监管模式,实现试验用药品闭环管理。实施后,试验用药品质控问题减少,管理更加规范。卫星药房可作为GCP药房的补充,确保试验用药品安全,提升临床试验质量。

Standardized management of trial drugs contributes to improving the level of pharmaceutical clinical research.Sat-llite pharmacy was constructed from hardware facilities,personnel,qualification,document management,quality control and other aspects,and GCP pharmacy supervision mode was adopted to realize closed-loop management of trial drugs.After implementation,the frequency of quality control problems of tril drugs decreased and management became more standardized.Satellite pharmacy can be used as a supplement to GCP pharmacy,ensuring the safety of trial drugs and improving the quality of clinical trials.