分析統(tǒng)計國家食品藥品監(jiān)督管理局藥品認證管理中心近3年來組織的42次GLP認證的現(xiàn)場檢查結(jié)果，列舉了被檢查實驗室出現(xiàn)的共性問題和由此導(dǎo)致的缺陷結(jié)果。在對比較常見的10類缺陷項目，如組織機構(gòu)和人員、實驗過程、動物和實驗設(shè)施、供試品和對照品、儀器設(shè)備、動物用品、標(biāo)準(zhǔn)操作規(guī)程（SOP）等方面問題進行具體分析的同時，提出整改措施和改進建議，以期幫助受檢研究機構(gòu)提升GLP管理水平，提高現(xiàn)場核查的通過率，為新藥臨床研究保駕護航。

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.