GB/T 22275.4-2008 in English
VALIDRequirements of conduct for good laboratory practice - Part 4: The application of the GLP principles to field studies
- Issued on:2008-08-04
- Implemented on:2009-04-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$146.00
《GB/T 22275.4-2008良好实验室规范实施要求 第4部分:良好实验室规范原则在现场研究中的应用》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4部分。
GB/T 22275的本部分规定了现场研究的试验机构的组织和人员、质量保证计划、试验设施、仪器、原料、试剂、试验系统、试验样品和参照物、标准操作程序、研究结果的报告、记录和材料的存储和保留。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、农药、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。
本部分做了下列编辑性修改:
――删除了前言和目录部分。
Scope
This part of GB/T 22275 specifies the organization and personnel of the testing organization, quality assurance plan, testing facilities, instruments, raw materials, reagents, testing systems, testing samples and reference materials, standard operating procedures, reports and records of research results for on-site research. and storage and retention of materials. In addition to the explicit exemption of national legislation, the principles of good laboratory practice (hereinafter referred to as GLP principles) stipulated in this part are applicable to non-clinical health and environmental safety research required by regulations, including pharmaceuticals, pesticides, food additives and feed additives, Registration or licensing of cosmetics, veterinary drugs and similar products, and management of industrial chemicals.

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