浅谈GLP原则下的档案管理  

A Brief Discussion on Archives Control in Compliance with GLP Principles

作　　者：李敏 任晓东 刘亮 梁慧芯 林荣华 Li Min;Ren Xiaodong;Liu Liang;Liang Huixin;Lin Yonghua(Institute for the Control of Agrochemicals,Ministry of Agriculture and Rural Affairs,P.R.China,Beijing 100125,China)

机构地区：[1]农业农村部农药检定所,北京100125

出　　处：《农药科学与管理》2024年第11期1-7,共7页Pesticide Science and Administration

摘　　要：在农药登记试验单位运行中,档案管理对于确保试验可靠性和完整性以及数据的可追溯性起着重要作用。由于不同来源GLP法规文件对档案管理的要求不完全一致,以及对有关规则的掌握不全面、理解不准确,档案管理方面的偏离在试验单位检查中较为常见。本文梳理了不同GLP监管框架下档案管理要求,包括不同类型档案的保存期限、QA档案的保存地点以及档案管理员在组织机构中的位置等问题,为明确档案管理要求提供参考借鉴。In the operation of pesticide registration test facilities,archive control plays an important role for ensuring the reliability and integrity of studies,as well as the traceability of data.Due to variations in archive management requirements across GLP regulatory documents from different sources,along with misunderstanding of GLP principles,have led to common deviations in archive management during test facility inspections.This article summarized the requirements for archive management under different GLP regulatory frameworks,including the retention period for different types of archives,the storage location of QA archives,and the position of archivist in the facility,providing reference and guidance for clarifying archive management requirements.

关 键 词：档案 良好实验室规范 农药登记试验单位 经济合作与发展组织 美国国家环境保护局 

分 类 号：S482[农业科学—农药学]