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International Federation for Consulting GmbH IFC

Validation on the basis of Commission Decision 2002/657/EC by Dr. Michael Scheutwinkel. International Federation for Consulting GmbH IFC. Did you sleep well?.

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International Federation for Consulting GmbH IFC

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  1. Validation on the basis of Commission Decision 2002/657/EC by Dr. Michael Scheutwinkel International Federation forConsulting GmbH IFC

  2. Did you sleep well?

  3. Validation shall demonstrate that the analytical method complies with the criteria applicable for the relevant performance characteristics (= is fit for purpose). Commission Decision 2002/657/EC, validation Banned substances (no permitted limits) MRL substances Screening methods Confirmatory methods

  4. Commission Decision 2002/657/EC Table 10

  5. Commission Decision 2002/657/EC

  6. Commission Decision 2002/657/EC

  7. Commission Decision 2002/657/EC

  8. Commission Decision 2002/657/EC

  9. CRL Guidance Paper 7 December 2007 … state of the art…

  10. CRL Guidance Paper 7 December 2007 MRPLs for MRL substances … state of the art…

  11. CRL Guidance Paper 7 December 2007 MRPLs for banned substances … state of the art…

  12. Commission Decision 2002/657/EC

  13. Commission Decision 2002/657/EC

  14. Commission Decision 2002/657/EC

  15. Commission Decision 2002/657/EC

  16. How to establish CCa …

  17. Commission Decision 2002/657/EC

  18. How to establish CCa … for banned substances In practice … • Calibration curves with very low ao values and low SDwiR are common. That mean CCa gets unreasonable low. In this case CCa is calculated as • CCa = C1 + 2.33 x SDwiR

  19. How to establish CCa … for MRL substances CCa = (fortification at MRL level + 1.64 x SDwiR) Calibration curve: 0, 0.5, 1.0, 2.0 and 2.5-fold MRL We need the within-laboratory reproducibility taken from the three series of checking the internal reproducibility at MRL-level Recovery corrected

  20. Commission Decision 2002/657/EC Three times the signal to noise ratio can be used as decision limit.

  21. Commission Decision 2002/657/EC

  22. For MRL substances CCa = fortification at MRL level + 1.64 x SDwiR CCß = fortification atMRL + 3.28 x SDwiR

  23. Commission Decision 2002/657/EC

  24. Commission Decision 2002/657/EC

  25. Commission Decision 2002/657/EC

  26. Commission Decision 2002/657/EC

  27. How to establish CCß … For banned substances CCß = CCa + 1.64 x SDwiRCCa For MRL substances CCß = MRL + 3.28 x SDwiRMRL

  28. For MRL substances CCa = fortification at MRL level + 1.64 x SDwiR CCß = fortification atMRL + 3.28 x SDwiR

  29. Commission Decision 2002/657/EC

  30. Commission Decision 2002/657/EC

  31. Commission Decision 2002/657/EC

  32. Commission Decision 2002/657/EC

  33. Tools Truneness Specifity Stability Calibration curve • Recovery Repeatability Decision limit CCα Detection capability CCβ Within-laboratory reproducibiity Applicability Reproducibility Ruggedness

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