概述:描述保留适当批次产品和相关材料的保留样品的方法，以及获取、识别、存储和记录适用于每个批次保留样品的适当信息的方法。适用于成品和某些组件的保留样品。也适用于收到用于产品和组件的化学品和其他原材料的保留样品。包括符合21 CFR第211.170部分的规定。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: 制造商零件的保留样品记录表，Purhcase零件的保留样品记录表关于本文件:这不是一个通用模板，它是一个5页的程序，实际上是在FDA监管机构的质量控制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在做什么，哪些公司会从中受益: 质量保证经理制造经理质量控制人员

Summary:Describes methods for retaining reserve samples of appropriate lots of product and related materials, and for obtaining, identifying, storing and documenting appropriate information as it applies to retention samples from each lot. Applies to retention samples of finished goods and certain subassemblies. Also applies to retention samples of chemical and other raw materials received for use in product and subassemblies. Includes provisions for compliance with 21 CFR Part 211.170.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Retention Sample Logsheet for Manufacturer Parts, Retention Sample Logsheet for Purhcase PartsAbout This Document:This is not a generic template, it's a 5-page procedure that was actually created and used in the Quality 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:Quality Assurance ManagersManufacturing ManagersQuality Control Personnel