[关键词]
[摘要]
分析统计国家食品药品监督管理局药品认证管理中心近3年来组织的42次GLP认证的现场检查结果,列举了被检查实验室出现的共性问题和由此导致的缺陷结果。在对比较常见的10类缺陷项目,如组织机构和人员、实验过程、动物和实验设施、供试品和对照品、仪器设备、动物用品、标准操作规程(SOP)等方面问题进行具体分析的同时,提出整改措施和改进建议,以期帮助受检研究机构提升GLP管理水平,提高现场核查的通过率,为新药临床研究保驾护航。
[Key word]
[Abstract]
Based on the analysis of inspection reports on 42 times of GLP compliance monitoring for GLP test facilities in the past 3 years, conducted by CCD (Center for Certification of Drug, CFDA), we listed 10 types of frequent defectives in such aspects as organization and personnel, conduction of experiments, animals and experimental establishments, test samples and control substance, instruments and equipments, animal supplies, SOP, etc. Besides analyzing the specific defectives, we put forward some solutions and suggestions that are promising to help improve the management of GLP test facilities, promote the qualification rate of GLP inspections, and consequently build the solid foundation for future clinical study on new drugs.
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