圍繞藥品非臨床研究質(zhì)量管理規(guī)范（GLP）體系下生殖發(fā)育毒性評(píng)價(jià)所使用儀器確認(rèn)展開(kāi)討論，提供開(kāi)展儀器確認(rèn)所需要的關(guān)鍵事項(xiàng)：根據(jù)研究目的，選取合適種屬的實(shí)驗(yàn)動(dòng)物；動(dòng)物數(shù)量應(yīng)滿足統(tǒng)計(jì)學(xué)需求；準(zhǔn)確選取實(shí)驗(yàn)受試物，購(gòu)入標(biāo)準(zhǔn)品或陽(yáng)性藥物；確定實(shí)用性強(qiáng)、干擾因素少的確認(rèn)方法；把握實(shí)驗(yàn)關(guān)鍵點(diǎn)、排除其他因素對(duì)確認(rèn)的干擾；建立準(zhǔn)確度高可重現(xiàn)性好的評(píng)價(jià)標(biāo)準(zhǔn)；根據(jù)實(shí)驗(yàn)室基本情況以及研究目的，在標(biāo)準(zhǔn)作業(yè)程序（SOP）中規(guī)定不同儀器確認(rèn)所需要的周期。現(xiàn)有生殖毒性儀器確認(rèn)規(guī)范性、標(biāo)準(zhǔn)化成為實(shí)驗(yàn)室管理的新難點(diǎn)，需要努力推進(jìn)其標(biāo)準(zhǔn)化規(guī)范化進(jìn)程。

This paper focused on how to successfully carry out equipment qualification of nonclinical reproductive toxicity study on drugs. The following issues are principally argued. Select the appropriate species of laboratory animal; Animal number should meet the statistical requirements; Accurate selection of experimental subjects; Determine the practicability and less interference verification method; Grasp the key points and the exclusion of other factors interference to verify accuracy; A high reproducibility of the evaluation criteria; According to the basic situation of laboratory and research, regulate the cycle of different instrument validation required in SOP. The evaluation system still have some disadvantages, and the reliability of performance has become a new problem of laboratory management.