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21 CFR 第 11 部分关于在线 WFI 仪器的数据完整性要求 本文探讨了在 WFI(注射用水)的质量控制环节,如何配置关键质量控制的在线总有机碳(TOC)和电导率分析仪,从而帮助客户满足 FDA 对数据完整性的要求,包括 Microsoft Active Directory(微软活动目录)控件的使用以及 PDF 数据的规范导出。
ICH Q2 – the Challenge of Measuring Total Organic Carbon in Modern Pharmaceutical Water Systems <span style="color: #4d4d4d;">Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters</span><span style="color: #4d4d4d;">. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document</span><span style="color: #4d4d4d;">2</span><span style="color: #4d4d4d;">&nbsp;from the International Conference on Harmonisation.</span>

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