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Chapter 3.1. VALIDATION PROCEDURES

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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. 1.

    a set of common performance characteristics independent of the validation model used and

  2. 2.

    more specific model-dependent procedures as described in Table 10.

Table 10

Model-independent and model-dependent performance parameters

Validation
Model-independent performance parametersModel-dependent performance parameters
Common performance characteristics (3.1.1)Conventional validation approach (3.1.2)In-house validation approach (3.1.3)
SpecificityRecoveryRecovery
TruenessRepeatabilityRepeatability
Ruggedness: minor changesWithin-laboratory reproducibilityWithin-laboratory reproducibility
StabilityReproducibilityReproducibility
Decision limit (CC α)Decision limit (CC α)
Detection capability (CCβ)Detection capability (CCβ)
Calibration curvesCalibration curve
Ruggedness: major changesRuggedness
  1. 3.1.1Model-independent performance characteristics
  2. 3.1.1.1Specificity
  3. 3.1.1.2Trueness
  4. 3.1.1.3Applicability/ruggedness (minor changes)
  5. 3.1.1.4Stability
  6. 3.1.1.5Calibration curves
  7. 3.1.2Conventional validation procedures
  8. 3.1.2.1Recovery
  9. 3.1.2.2Repeatability
  10. 3.1.2.3Within-laboratory reproducibility
  11. 3.1.2.4Reproducibility
  12. 3.1.2.5Decision Limit (CCɑ)
  13. 3.1.2.6Detection capability (CCβ)
  14. 3.1.2.7Ruggedness (major changes)
  15. 3.1.3Validation according to alternative models
  16. 3.1.3.1Experimental plan
  17. 3.1.3.2Power curve
  18. 3.1.3.3Reproducibility

Notes on Annex I

Textual amendments

F1

Replaced by virtue of 2003/181/EC: Commission Decision of 13 March 2003 amending Decision 2002/657/EC as regards the setting of minimum required performance limits (MRPLs) for certain residues in food of animal origin (Text with EEA relevance) (notified under document number C(2003) 764)