概述:描述返工和再加工操作的程序，包括确保调查所有返工或再加工操作的原因所需的程序，以便识别和实施变更，以防止未来的流程故障。适用于药品、生物和医疗器械产品的返工。也适用于不符合规范的批次的再加工。包括确定返工/再加工是否合适，以及执行批准的返工/再加工订单的规定。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:返工或再加工说明、QC检验服务请求和批次摘要关于本文件:这不是通用模板，这是一个长达7页的程序，实际上是在FDA的GMP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:制造经理物料控制人员质量控制人员

Summary:Describes the procedures for rework and reprocessing operations, including the procedures necessary to ensure that causes for all rework or reprocessing operations are investigated so that changes can be identified and implemented to prevent future process failures. Applies to the reworking of drug, biologic and medical device products. Also applies to the reprocessing of batches that do not conform to specifications. Includes provisions for determining whether rework/reprocess is appropriate, and execution of approved rework/reprocess orders.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Rework Or Reprocessing Instructions, QC Inspection Services Request and Lot SummaryAbout This Document:This is not a generic template, it's a 7-page procedure that was actually created and used in the GMP 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:Manufacturing ManagersMaterial Control PersonnelQuality Control Personnel