概述:描述了为验证产品无菌测试方法而进行抑菌和抑菌测试的程序。适用于所有进行无菌测试的物品，其中需要按照个别操作程序和/或pH armacopoeias的规定测定抑菌和抗真菌水平。也适用于散装容器和最终容器，其中散装体积至少为10毫升，最终容器小于10毫升，以及需要进行抑菌/抑菌试验的成品或设备。包括符合USP 23的规定- NF 18<71>，《欧洲药典》第三补充版和21 CFR第610.12（e）（2）（vi）部分。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:直接接种抑菌/抑真菌试验和膜过滤抑菌/抑真菌试验关于本文件:这不是通用模板，这是一个长达6页的程序，实际上是在一家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，谁会从中受益:质量保证经理制造经理质量控制人员

Summary:Describes procedures of performing bacteriostasis and fungistasis test for validating a product sterility test method. Applicable to all articles that are tested for sterility where determination of bacteriostasis and fungistasis levels are required as specified in individual operating procedures, and/or pH armacopoeias. Also applies to bulk and final containers where the bulk volume is at least 10 mL and final containers are less than 10 mL, and to to finished products or devices where bacteriostasis/fungistasis tests are required. Includes provisions for compliance with USP 23-NF 18 <71>, European Pharmacopoeia 3rd Supp., and 21 CFR Part 610.12(e)(2)(vi).Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Direct Inoculation Bacteriostasis/Fungistasis Test, and Membrane Filtration Bacteriostasis/Fungistasis TestAbout 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