Standard Guide for Validating Analytical Methods

Importancia y uso:

4.1 Method validation is a process of demonstrating that the method meets the required performance capabilities. International standards such as ISO/IEC 17025, certifying bodies, and regulatory agencies require evidence that analytical methods are capable of producing valid results. This applies to laboratories using published standard test methods, modified standard test methods, and in-house test methods.

4.2 Although a collaborative study is part of this guide, this guide may be used by a single laboratory for method validation when a formal collaboration study is not practical. This guide may also be applied before a full collaboration study to predict the reliability of the method.

4.3 The use of multiple validation techniques described in this guide increases confidence in the validity or application of the method.

4.4 It is beyond the scope of this guide to describe fully the fundamental considerations in Section 5. For a more descriptive definition of these concepts, refer to the International Union of Pure and Applied Chemistry (IUPAC) technical report, “Harmonized Guidelines for Single Laboratory Validation of Methods of Analysis” (1), the IUPAC Compendium of Analytical Nomenclature (Orange Book) (2), and the Eurachem publication, The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics (3).

Subcomité:

E01.22

Referida por:

E2792-21, D8282-19, F3127-22, E1085-22, D8543-24, E2823-17, D8421-24, E0572-21, E1621-22, E2465-23, E1085-22, E2972-15R19, E1447-22, D8282-19, E1172-22, D8535-23, E3346-22, D8456-22, E1085-22, F2102-17, E0539-19, E2994-21, E3047-22, E3061-24, E2371-21A, E1019-24, D8272-19, E1019-24, E1019-24

Volúmen:

03.05

Número ICS:

71.040.40 (Chemical analysis), 71.040.50 (Physicochemical methods of analysis)

Palabras clave:

bias; limit of detection; limit of quantification; precision; ruggedness; selectivity; validation;