GLP实验室中QAU的检查类型及其功能
Chinese Pharmaceutical Affairs(2013)
Abstract
目的确保GLP实验室中非临床试验的质量和完整性。方法QAU检查包括基于试验的检查(Study-based inspection)、基于过程的检查(Process-based inspection)和基于设施的检查(Facility-based inspection)。结果实验室的GLP规范遵从水平维持良好。结论QAU须从不同的试验或设施的多种角度或不同水平进行检查,不断提高GLP规范遵从水平。
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Key words
GLP,QAU,inspections
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