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现行 DOXPUB 16-0007-SOP
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General Laboratory Procedures: Quality Control (QC) 一般实验室程序:质量控制(QC)
发布日期: 2007-08-01
概述:描述了一种程序,以确保在本实验室进行的免疫细胞化学程序中使用的所有试剂和仪器的适当质量控制。适用于所有处理、免疫染色或解释患者标本结果的实验室人员。包括标本处理请求、固定剂、Ficol Hypaque、缓冲溶液、免疫染色试剂盒/试剂、实验室仪器、组织培养培养箱、生物安全柜、离心机和细胞离心机的规定。包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括附件/附录: 关于本文件:这不是一个通用模板,它是一个3页的程序,实际上是在FDA监管机构的实验室研发操作中创建和使用的。公司特定信息(名称、地址、一些图片、专有产品信息等)已被编辑,但内容和格式已基本保留。购买理由:将其作为你自己文档项目的起点,将你文档的质量与你所在行业的同行进行比较,了解你所在行业的其他公司实际在做什么,谁将从中受益:流程开发人员方法开发人员质量控制人员
Summary:Describes a procedure to assure proper quality control of all reagents and instrumentation that are used in immunocytochemical procedures performed in this laboratory. Applies to all laboratory personnel who process, immunostain, or interpret the results of patient specimens. Includes provisions for specimen processing requests, fixatives, Ficol-Hypaque, buffer solutions, immunostaining kits/reagents, laboratory instrumentation, tissue culture incubators, biological safety cabinets, centrifuges, and cytocentrifuges.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:NoneAbout This Document:This is not a generic template, it's a 3-page procedure that was actually created and used in the Laboratory R&D operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Process Development PersonnelMethod Development PersonnelQuality Control Personnel
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