毒性病理评价的质量保证

Quality assurance of toxic pathological evaluations

毒性病理学评价是一般毒性试验、啮齿类致癌性试验以及一般生殖毒性试验的重要组成部分,在GLP质量管理和质量保证(QA)检查方面有其特殊的要求。现从试验人员、设施资质的确认、实验室质量控制,质量评估措施,病理资科、报告和材料的核查等方面详细介绍了毒性病理学评阶QA的程序,要求和重点考虑的问题。

Toxic pathological evaluations are of significant importance that placed in a specialized category among others, such as the general toxicily tests, rodent carcinogenicity assays and the reproductive toxicity tests. Additionally, the evaluations have also evident and intensive standards in the GLP management and quality assurance (QA) inspections. This paper comprehensively reviewed the procedures, emphases, and the potential hurdles of the QA inspection for the toxic pathological evaluations with respect of the experiment personnel, testing facility qualifications, laboratory quality control, quality assessment approaches, and the audits of the pathological data, reports and materials.