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GLP机构病理部门工作规范化探讨

Standardization of pathology work in GLP facility

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【作者】 王佳楠曹彩

【Author】 WANG Jia-nan, CAO Cai Center for Certification of Drug, State Food and Drug Administration, Beijing 100061, China

【机构】 国家食品药品监督管理局药品认证管理中心

【摘要】 病理部门是GLP机构中的重要组成部分,承担着毒性病理学检查任务。在我国GLP法规的基础上,从检查流程、标本保管、原始记录、人员资质、安全防护和仪器使用等方面介绍病理工作中应注意的问题。建议GLP机构应重视病理部门的建设,病理部门应根据GLP原则,制定完善的SOP,加强人员培训,促进病理部门的规范化建设。

【Abstract】 Pathology department is an important part of good laboratory practice (GLP) facility, which carries the work of toxicological pathology. On the basis of Chinese GLP, several points to pay attention to regarding the process, storage, documentation, qualification, protection, and instrumentation of pathology work were introduced. GLP facilities should attach the importance to the construction of pathology department. The pathology department should develop sound SOP and strengthen training according to the principles of GLP to facilitate the standardization of pathology work.

【关键词】 GLP病理规范化
【Key words】 GLPpathologystandardization
【基金】 国家“十一五”新药创制重大专项(2009ZX09309-003)
  • 【文献出处】 药物评价研究 ,Drug Evaluation Research , 编辑部邮箱 ,2011年04期
  • 【分类号】R95
  • 【被引频次】4
  • 【下载频次】227
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