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。 The quality assurance department of GLP Laboratories refers to the department that supervises the quality of non-clinical research work to ensure that facilities, equipment, personnel, methods, operations, records and controls in GLP laboratories comply with GLP requirements Improve quality, ensure safety and pay attention to efficiency. In this paper, by explaining the common problems in the QA verification of thematic studies (including the experimental scheme, research site, original data and summary report), the reasons for the emergence of the problems and the suggestions to solve the problems are put forward.