组织病理学评估及同行评议的原始数据及GLP符合性解读

组织病理学评估是药物非临床安全性评价的重要环节，组织病理学同行评议不仅可以确保诊断术语的一致性和准确性，而且可以提高病理诊断的准确性和病理学报告的质量。因为GLP质量体系的核心是原始数据，所以要确保最终病理学报告能够真实反映原始数据。组织病理学评估和同行评议的原始数据是病理学报告重建和保证报告质量的基础。本文对国内外GLP法规对原始数据的定义、美国FDA对病理学原始数据的规定、国内外监管机构对组织病理学同行评议中原始数据的规定、不同类型组织病理学同行评议中的原始数据以及组织病理学同行评议的GLP符合性进行分析，希望为我国GLP机构更好地开展组织病理学评估及同行评议提供一定参考。

Interpretation of Raw Data and GLP Compliance for Histopathology Assessment and Peer Review

Histopathology assessment is an important part of nonclinical safety evaluation of drugs. Histopathology peer review can not only ensure the consistency and accuracy of pathology diagnostic terms, but also improve the accuracy of pathology diagnosis and the quality of pathology report. Because the core of the GLP quality system is raw data, it is necessary to ensure that the raw data are truly reflected in the final pathology report. The raw data for histopathology assessment and peer review are the basis for reconstruction and the quality of the pathology report. In this paper, definitions of raw data in GLP regulations at home and abroad, regulation on pathology raw data of US FDA, regulations on the raw data in the pathological peer review of regulatory agencies at home and abroad, raw data in different kinds of histopathological peer review, as well as GLP compliance of histopathology peer review were analyzed in order to provide references for GLP facilities to better carry out the histopathology assessment and peer review in China.