OECD组织病理学同行评议GLP要求指导原则解读  

Interpretation of the OECD Guidance on the GLP Requirements for Peer Review of Hisopathology

作　　者：吕建军[1] 屈哲[1] 霍桂桃[1] 林志[1] 杨艳伟[1] 张頔[1] 张硕[1] 李波[2] 

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心、药物非临床安全评价研究北京市重点实验室,北京100176 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2016年第10期968-976,共9页Chinese Pharmaceutical Affairs

基　　金：科技部“十二五”重大新药创制专项(编号2012ZX09302001);“重大新药创制”科技重大专项课题(编号2015ZX09501007-004)

摘　　要：毒性病理学是药物非临床安全性评价的重要组成部分,组织病理学评价是药物毒理学研究最重要的方法之一。组织病理学同行评议可核实及提高病理诊断和解释的准确性,提高病理报告的质量,同时也可作为毒性病理学家继续教育的重要组成部分。2012年经济合作和发展组织颁布了指导性文件第116号,其中的"3.6.3.7"部分是有关如何实施组织病理学同行评议,2014年经济合作和发展组织颁布了良好实验室规范和符合性监督原则系列文件第16号组织病理学同行评议GLP要求指导原则,目的是指导病理学家、试验机构管理者、项目负责人和质量保证人员在实施组织病理学同行评议中如何进行策划、管理、记录和报告,以符合GLP要求。本文首先简要介绍了OECD指导性文件第116号"3.6.3.7"部分有关如何实施组织病理学同行评议;其次重点介绍了OECD组织病理学同行评议的GLP要求指导原则的背景、GLP要求、同行评议的GLP符合性及总结,并提供了全球毒性病理组织对OECD组织病理学同行评议GLP要求指导原则每一条内容的解读,目的是对上述指导原则提供统一的解释,推荐实施标准过程,以避免我国毒性病理行业使用不一致的程序开展同行评议;最后简要介绍了中国国家认证认可监督管理委员会发布的良好实验室规范在组织病理学同行评议中的应用指南,以期为我国药物非临床安全性评价领域在GLP条件下更好地开展组织病理学同行评议提供一些参考。Toxicologic pathology is an important part of the nonclinical safety evaluation of drugs. Histopathological assessment is one of the important methods of toxicology study of drugs. Peer review of histopathology verifies and improves the accuracy of the pathology diagnoses and interpretation, improves thequality of the pathology report, serves as an important source of continuing education of toxicological pathologists In 2012, the organisation for economic cooperation and development（OECD） issued guidance document No.116 on the conduct and design of chronic toxicity and carcinogenicity studies. The 3.6.3.7 section of OECD guidance document No.116 focuses on peer review of histopathology. In 2014, OECD issued guidance No.16, guidance on the GLP requirements for peer review of histopathology. The stated purpose of the guidance document is to provide guidance to pathologists, test facility management, study directors and quality assurance personnel on how the peer review of histopathology should be planned, managed, documented, and reported in order to meet Good Laboratory Practice（GLP） expectations and requirements. Firstly, the paper briefly introduced the 3.6.3.7 section of OECD guidance document No.116 on how to carry out peer review of histopathology. Secondly, the paper emphasized the background, GLP requirements, GLP compliance of peer review and summary of expectations of the OECD guidance on the GLP requirements for peer review of histopathology. Furthermore, the paper also provided an item-by-item interpretation of the guidance presented by global toxicologic pathology community, with the aim to provide a unified interpretation of the guidance, to recommend standard processes for organizations to implement, and to avoid inconsistent process adaptations across the toxicologic pathology industry of China. Finally, the paper gave a brief introduction to the guidance for the application of Good Laboratory Practice for peer review of histopathology issued by certification and accreditation administratio

关 键 词：非临床研究 良好实验室规范 毒性病理学 组织病理学 同行评议 指导原则 经济合作和发展组织 

分 类 号：R95[医药卫生—药学] R99