ICH Q2 (R1) Validation of analytical procedures: text and methodology

Table of contents

This document discusses the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the EC, Japan and USA. It serves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation.

Keywords: Validation, analytical procedures, accuracy, precision, specificity, detection limit, quantitation limit, linearity, range

Published: 01/11/1994 (part I); 01/12/1996 (part II)
Effective from: 01/06/1995 (part I); 01/06/1997 (part II)

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