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

2. 2 Did you sleep well?

3. 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) Banned substances (no permitted limits) MRL substances Screening methods Confirmatory methods

4. 4 Commission Decision 2002/657/EC Table 10

5. 5 Commission Decision 2002/657/EC

6. 6

7. 7

8. 8

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

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

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

12. 12 Commission Decision 2002/657/EC

13. 13 Commission Decision 2002/657/EC

14. 14 Commission Decision 2002/657/EC

15. 15 Commission Decision 2002/657/EC

16. 16 How to establish CCa …

17. 17 Commission Decision 2002/657/EC

18. 18 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 = C 1 + 2.33 x SDwiR How to establish CCa … for banned substances

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

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

21. 21 Commission Decision 2002/657/EC

22. 22

23. 23

24. 24 For MRL substances CCa = fortification at MRL level + 1.64 x SDwiR CCß = fortification at MRL + 3.28 x SDwiR For MRL substances CCa = fortification at MRL level + 1.64 x SDwiR CCß = fortification at MRL + 3.28 x SDwiR

25. 25 Commission Decision 2002/657/EC

26. 26 Commission Decision 2002/657/EC

27. 27 Commission Decision 2002/657/EC

28. 28 Commission Decision 2002/657/EC

29. 29 How to establish CCß … For banned substances CCß = CCa + 1.64 x SDwiR CCa For banned substances CCß = CCa + 1.64 x SDwiR CCa For MRL substances CCß = MRL + 3.28 x SDwiR MRL For MRL substances CCß = MRL + 3.28 x SDwiR MRL

30. 30 For MRL substances CCa = fortification at MRL level + 1.64 x SDwiR CCß = fortification at MRL + 3.28 x SDwiR For MRL substances CCa = fortification at MRL level + 1.64 x SDwiR CCß = fortification at MRL + 3.28 x SDwiR

31. 31 Commission Decision 2002/657/EC

32. 32 Commission Decision 2002/657/EC

33. 33 Commission Decision 2002/657/EC

34. 34 Commission Decision 2002/657/EC

35. 35 Tools Decision limit CCα Decision limit CCα Recovery Recovery Repeatability Ruggedness Within-laboratory reproducibiity Within-laboratory reproducibiity Reproducibility Truneness Detection capability CCβ Detection capability CCβ Calibration curve Specifity Stability Applicability