GB/T 22274.1-2008 in English
VALIDGuidance for GLP monitoring authorities - Part 1: Guides for compliance monitoring procedures for good laboratory practice
- 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 22274.1-2008良好实验室规范监督部门指南 第1部分:良好实验室规范符合性监督程序指南》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 22274《良好实验室规范监督部门指南》分为3个部分,本部分为GB/T 22274的第1部分。
本部分等同采用经济合作与发展组织(OECD)良好实验室规范(GLP)原则和符合性监督系列文件No.2:《良好实验室规范监督部门导则:修订的GLP符合性监督程序指南》[OCDE/GD(95)66]。
GB/T 22274的本部分规定了良好实验室规范中监督部门的行政管理、保密性、人员和培训、GLP符合性计划、试验机构检查和研究审核的后续工作、申诉程序。本部分适用于在我国境内设立的GLP监督部门。
本部分进行了下列编辑性修改:
――删除了原文中的(1)前言和引言;(2)第二部分:与GLP原则及符合性监督有关的OECD理事会法案。
Scope
This part of GB/T 22274 specifies the administrative management, confidentiality, personnel and training, GLP conformity plan, follow-up work and appeal procedure of the inspection and research audit of the testing institution in the supervision department in the good laboratory practice. This part is applicable to the GLP supervision departments established in my country.

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