GB/T 22275.7-2008 in English
VALIDRequirements of conduct for good laboratory practice - Part 7: The application of the GLP principles to the organisation and management of multi-site studies
- Issued on:2008-08-04
- Implemented on:2009-04-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$97.00
《GB/T 22275.7-2008良好实验室规范实施要求 第7部分:良好实验室规范原则在多场所研究的组织和管理中的应用》由TC251(全国危险化学品管理标准化技术委员会)归口,主管部门为国家标准化管理委员会。
GB/T 22275《良好实验室规范实施要求》分为7个部分,本部分为GB/T 22275的第7部分。GB/T 22275的本部分规定了多场所研究的管理和控制、质量保证、主进度表、研究计划、研究的实施、研究结果的报告、标准操作程序、记录和材料的存储和保管。除了国家立法的明确豁免,本部分所规定的良好实验室规范原则(以下简称GLP原则)适用于法规所要求的所有非临床健康和环境安全研究,包括医药、杀虫剂、食品添加剂与饲料添加剂、化妆品、兽药和类似产品的注册或申请许可证,以及工业化学品管理。
Scope
This part of GB/T 22275 specifies the management and control, quality assurance, master schedule, research plan, implementation of research, reporting of research results, standard operating procedures, storage and preservation of records and materials. Except for clear exemptions provided by national legislation, the Good Laboratory Practice principles (referred to as GLP principles) specified in this part apply to all non-clinical health and environmental safety studies required by regulations, including registration or application for licenses related to pharmaceuticals, pesticides, food additives and feed additives, as well as industrial chemicals management.

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