# Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (notified under document number C(2002) 3044) (Text with EEA relevance) (2002/657/EC), Chapter 3.1.: VALIDATION PROCEDURES

Extent: E+W+S+N.I.

This chapter provides examples and/or references for validation procedures of analytical methods. Other approaches to demonstrate that the analytical method complies with performance criteria for the performance characteristics may be used, provided that they achieve the same level and quality of information.
Validation can also be performed by conducting an interlaboratory study such as established by Codex Alimentarius, ISO or the IUPAC (12), or according to alternative methods such as single laboratory studies or in-house validation (13)(14). This part focuses on single laboratory studies (on in-house validation) using a modular approach. This approach consists of:
1. a set of common performance characteristics independent of the validation model used and
2. more specific model-dependent procedures as described in Table 10.
Table 10
Model-independent and model-dependent performance parameters
Validation
Model-independent performance parameters
Model-dependent performance parameters
Common performance characteristics (3.1.1)
Conventional validation approach (3.1.2)
In-house validation approach (3.1.3)
Specificity
Recovery
Recovery
Trueness
Repeatability
Repeatability
Ruggedness: minor changes
Within-laboratory reproducibility
Within-laboratory reproducibility
Stability
Reproducibility
Reproducibility
Decision limit (CC α)
Decision limit (CC α)
Detection capability (CCβ)
Detection capability (CCβ)
Calibration curves
Calibration curve
Ruggedness: major changes
Ruggedness

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Source: https://www.legislation.gov.uk/eudn/2002/657/annex/chapter/3.1 (the official version)
Page: https://openlegislation.uk/eu-decision-2002-657/annex/chapter-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.