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质量保证部门(QAU)是指符合良好实验室规范(GLP)的非临床安全性评价测试机构内履行有关非临床测试工作质量保证职能的部门[1]。质量保证(QA)人员作为QAU的关键参与者,从职责的角度分析虽然仅限于对测试过程中发生的错误提出有效的纠正措施,并且原则上不对具体测试技术层面的内容进行审[]
Quality Assurance Department (QAU) refers to the department that performs the quality assurance functions related to non-clinical testing within a GLP-compliant non-clinical safety testing organization [1]. Quality Assurance (QA) personnel, as key QAU participants, analyze from the perspective of responsibility only valid remedies for mistakes in the testing process and do not in principle test specific technical aspects of testing