药品研发质量体系数据完整性的现状及应对措施  

Current Situation of Data Integrity during Drug Research and Development and Its Related Measures

作　　者：汪六英 周自桂 李瑞[1] 秦勇[1] WANG Liu-ying;ZHOU Zi-gui;LI Rui;QIN Yong(Pharmaceutical Research Institute,Jiangsu Shenlong Pharmaceutical Co.,Ltd.,Jiangsu Nanjing 210029,China)

机构地区：[1]江苏神龙药业有限公司药物研究院,江苏南京210029

出　　处：《广州化工》2019年第3期161-163,共3页GuangZhou Chemical Industry

摘　　要：通过对药品数据可靠性指南及规范的学习,分析CFDA2016-2017年度药品检查报告中数据完整性问题缺陷项,总结平时工作中存在的数据完整性常见问题。根据CFDA 《药品数据管理规范》征求意见稿及新版《药品生产质量管理规范(2010年修订)》中计算机化附录的要求,针对药品研发质量体系数据完整性工作,提出一些应对措施。Through the study of data reliability guidelines and standard, the defects in drug inspection reports from 2016 to 2017 from CFDA were analyzed, and problems of data integrity in daily work were summarized.According with the requirements of the draft of Drug Data Management Standard and the computerized appendix of GMP (revised in 2010), some countermeasures for data integrity of the quality control system of drug research and development were put forward.

关 键 词：数据完整性 数据可靠性 方法与措施 药品研发质量体系 

分 类 号：R-1[医药卫生]