圍繞藥品非臨床研究質量管理規(guī)范（GLP）體系下生殖發(fā)育毒性評價所使用儀器確認展開討論，提供開展儀器確認所需要的關鍵事項：根據(jù)研究目的，選取合適種屬的實驗動物；動物數(shù)量應滿足統(tǒng)計學需求；準確選取實驗受試物，購入標準品或陽性藥物；確定實用性強、干擾因素少的確認方法；把握實驗關鍵點、排除其他因素對確認的干擾；建立準確度高可重現(xiàn)性好的評價標準；根據(jù)實驗室基本情況以及研究目的，在標準作業(yè)程序（SOP）中規(guī)定不同儀器確認所需要的周期。現(xiàn)有生殖毒性儀器確認規(guī)范性、標準化成為實驗室管理的新難點，需要努力推進其標準化規(guī)范化進程。

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.