摘要:描述了一种通过直接接种对小体积液体物品进行无菌检测的方法。适用于需要进行无菌检测的液体物品，这些物品的制造或接收单位填充体积小于10毫升，以及接受无菌检查的物品。也适用于分类为“生物制品”的物品，并按照21 CFR 610.12直接转移无菌测试方法的要求进行测试。包括符合USP 23-NF 18第八次增补的规定。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:直接接种无菌检测报告关于本文件:这不是通用模板，而是6- 在FDA监管机构的质量控制操作中实际创建和使用的page程序。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:质量保证经理制造经理质量控制人员

Summary:Describes a method for sterility testing small volume liquid articles by direct inoculation. Applies to liquid articles requiring sterility testing that are manufactured or received by where the fill volume per unit is less than 10 mL, as well as articles examined for receiving inspection sterility. Also applies to articles classified as ¿biologics¿ and tested per the requirements of 21 CFR 610.12 direct transfer sterility test methods. Includes provisions for compliance with Eighth Supplement of USP 23-NF 18.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Direct Inoculation Sterility Test ReportAbout This Document:This is not a generic template, it's a 6-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