藥物非臨床安全性評(píng)價(jià)的質(zhì)量保證是整個(gè)管理體系建設(shè)的關(guān)鍵，是項(xiàng)目實(shí)施與管理規(guī)范一致性的保證，也是標(biāo)準(zhǔn)操作規(guī)程（SOP）嚴(yán)格執(zhí)行的動(dòng)力。質(zhì)量保證部SOP建設(shè)關(guān)系到部門人員的行為水準(zhǔn)，意義重大。其SOP內(nèi)容通?？煞譃?大類，并匹配有相應(yīng)的檢查表格等文件系統(tǒng)。各部分SOP應(yīng)圍繞質(zhì)量保證（QA）檢查、審查和監(jiān)查的具體操作行為來撰寫，簡(jiǎn)潔明了、條理清晰、行文規(guī)范，并具有可操作性。涉及的相關(guān)表格應(yīng)設(shè)計(jì)合理、流程及記錄完整，填寫方便簡(jiǎn)單，形成對(duì)質(zhì)量保證工作的有力支撐。

Quality assurance (QA) in drug non-clinical safety evaluation is the key to the construction of quality management system, and it is the conforming assurance of project research and management system, also the power of standard operating procedures strictly enforce. The construction quality of the QA department standard operation process (SOP) and check form are related to the personnel's behavior standard for quality assurance, and of great significance. The SOP content is usually divided into personnel post construction, overview of QA procedures and facilities construction of QA procedures, project implementation of QA procedures, supplier and multiple site research QA procedures construction, QA statement, etc, and matching with the corresponding inspection form. Each part of SOP should be around QA examination, inspection, and monitoring specific behavior to write, short and concise, clear, writing code, and operable. Involving related form should be rational design, process and record is complete, fill out the convenience simple, form a strong support for the work of QA personnel.