摘要:为零件号规范（PNS）建立标准化的格式、内容和样式要求。PNS是进入GMP最终产品的每个产品、子组件和材料的主要数据表。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的附件/附录:PNS主文件样式表、PNS主文件格式模板、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8页的程序，实际上是在FDA的文件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:文档控制人员配置管理质量保证经理

Summary:Establishes a standardized format, content, and style requirements for Part Number Specifications (PNS). PNSs are the primary datasheet for each product, subcomponent and material going into GMP final products.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:PNS Master Document Style Sheet, PNS Master Document Format Template, QC Inspection Services Request and Lot SummaryAbout This Document:This is not a generic template, it's a 8-page procedure that was actually created and used in the Document 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:Document Control PersonnelConfiguration ManagementQuality Assurance Managers