分析統(tǒng)計(jì)國(guó)家食品藥品監(jiān)督管理局藥品認(rèn)證管理中心近3年來(lái)組織的42次GLP認(rèn)證的現(xiàn)場(chǎng)檢查結(jié)果，列舉了被檢查實(shí)驗(yàn)室出現(xiàn)的共性問(wèn)題和由此導(dǎo)致的缺陷結(jié)果。在對(duì)比較常見(jiàn)的10類缺陷項(xiàng)目，如組織機(jī)構(gòu)和人員、實(shí)驗(yàn)過(guò)程、動(dòng)物和實(shí)驗(yàn)設(shè)施、供試品和對(duì)照品、儀器設(shè)備、動(dòng)物用品、標(biāo)準(zhǔn)操作規(guī)程（SOP）等方面問(wèn)題進(jìn)行具體分析的同時(shí)，提出整改措施和改進(jìn)建議，以期幫助受檢研究機(jī)構(gòu)提升GLP管理水平，提高現(xiàn)場(chǎng)核查的通過(guò)率，為新藥臨床研究保駕護(hù)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.