在藥物非臨床安全性評價良好實驗室規(guī)范（GLP）體系下依據(jù)規(guī)范產(chǎn)生的標(biāo)準(zhǔn)操作規(guī)程（SOP），構(gòu)成了GLP機構(gòu)運行的基本體系架構(gòu)，且在藥物非臨床安全性評價機構(gòu)的持續(xù)性組織運行和試驗實施過程中不斷吸收獲得的新經(jīng)驗、認(rèn)知，并借鑒其他機構(gòu)、行業(yè)、不同體系中的良好實踐做法，融入到現(xiàn)有體系內(nèi)，促進(jìn)和引領(lǐng)質(zhì)量管理體系持續(xù)改進(jìn)，以滿足日益嚴(yán)格的監(jiān)管機構(gòu)及委托方的合規(guī)性要求。依據(jù)國內(nèi)外GLP相關(guān)的指導(dǎo)原則，分析GLP規(guī)范與SOP的關(guān)系，并提出完善SOP質(zhì)量管理體系的途徑，以期為藥物非臨床安全性機構(gòu)優(yōu)化、提升質(zhì)量管理體系提供參考。

Under the Good Laboratory Practice (GLP) system, the Standard Operating Procedure (SOP) generated according to the GLP principles constitute the basic system framework for the operation of GLP test facilities, and will continue to absorb new experience and cognition during the test facilities' continuous organizational operation and study conduct process, and learn good practices from other test facilities, different quality systems, different industries, and integrate into the existing system, to promote and lead the continuous improvement of the quality management system of GLP test facilities to meet the compliance requirements of increasingly standardized and strict monitoring authorities and sponsors. Based on GLP at home and abroad and related guidelines, literature, etc., this paper analyzes the relationship between GLP principals and SOPs, and proposes various ways to improve the existing quality management system of GLP test facilities, to provide effective references for each test facility to optimize and improve its quality management system.

江蘇省新藥一站式高效非臨床評價公共服務(wù)平臺建設(shè)項目（BM2021002）