分析程序的开发和验证?

LCGC Europe Pub Date : 2022-07-01 DOI:10.56530/lcgc.eu.ue1079n4

Chris Burgess

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引用次数: 1

摘要

关于分析方法验证和开发的ICH Q2(R2)和Q14出版物草案对于受监管的良好生产规范(GMP)实验室意味着什么?它们是否与美国药典(USP)对分析程序生命周期所采用的方法一致?为什么要用ICH两份文件来描述USP可以做什么?

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Quo Vadis Analytical Procedure Development and Validation?

What do the draft publications ICH Q2(R2) and Q14 for analytical procedure validation and development mean for a regulated good manufacturing practice (GMP) laboratory? Are they consistent with the approach taken by the United States Pharmacopeia (USP) <1220> on Analytical Procedure Life Cycle? Why does it take the ICH two documents to describe what the USP can do in one?

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LCGC Europe

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