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Materials Control-Receiving Procedures 材料控制和接收程序
发布日期: 2007-08-01
概述:描述了一个程序,以便于验收、跟踪和处理所有采购的拟用于GMP产品制造的商品。适用于根据指定零件号购买的所有产品,用于制造。包括但不限于原材料(即化学品、试剂、缓冲剂等)子组件(即模塑件、预切割筛网等)和成品(即管组、PBS袋、RPMI袋、Pall过滤器等)的采购。包括的章节:目的、范围、责任、参考文件和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括的附件/附录:关于本文件的接收日志:这不是一个通用模板,它是一个4页的程序,实际上是在FDA的材料控制操作中创建和使用的- 受监管的机构。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在做什么,谁会从中受益:材料控制人员制造经理质量保证经理
Summary:Describes a procedure to facilitate the acceptance, tracking and processing of all goods purchased by intended for use in GMP product manufacturing. Applies to all products purchased by intended for use in manufacturing under assigned part numbers. Includes, but not limited to, the procurement of raw materials, (i.e. chemicals, reagents, buffers, etc.) sub-components, (i.e. molded plastic parts, pre-cut screens, etc.) and finished goods (i.e. tube sets, PBS bags, RPMI bags, Pall filters, etc.).Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Receiving LogAbout This Document:This is not a generic template, it's a 4-page procedure that was actually created and used in the Material Control 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:Material Control PersonnelManufacturing ManagersQuality Assurance Managers
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