GLP实验室专题研究QA核查常见问题探讨

Common problems in non-clinical laboratory studies revealed by QA inspection in GLP laboratories

GLP实验室的质量保证部门是指对非临床研究工作质量进行监督检查的部门,目的是确保GLP实验室的设施、仪器设备、人员、方法、操作、记录和对照品符合GLP要求,进而起到提高质量、确保安全和讲究效率的作用。本文通过阐述专题研究(包括试验方案、研究现场、原始资料和总结报告)QA核查中常见问题,探讨出现问题的原因,提出解决问题的建议。

Quality assurance（QA） unit in GLP laboratory is responsible for monitoring each study to assure whether the facilities,equipment,personnel,methods,practices,records and controls are in conformance with the regulations of GLP.It plays the role in improving quality,and ensuring safety and efficiency.In the present article,we briefly outlined the common problems of non-clinical laboratory studies（including protocols,the phase or segment of the study inspected,raw data and final study reports） revealed by QA inspection in GLP laboratories.The causes of the problems and propositions to solve the problems were discussed at the same time.