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Guideline for Industry: Text on Validation of Analytical Procedures

机译：行业指南：分析程序验证文本

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摘要

The document presents a discussion of the characteristics for considerationduring the validation of the analytical procedures included as part of registration applications submitted within the European Union, Japan and the United States. This document does not necessarily seek to cover the testing that may be required for registration in, or export to, other areas of the world. Furthermore, this text presentation serves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation. These terms and definitions are meant to bridge the differences that often exist between various compendia and regulators of the European Union, Japan and the United States.

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