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

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Presentation transcript:

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

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) 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

7

8

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

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

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

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 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 x SDwiR How to establish CCa … for banned substances

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 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 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 Commission Decision 2002/657/EC

22

23

24 For MRL substances CCa = fortification at MRL level x SDwiR CCß = fortification at MRL x SDwiR For MRL substances CCa = fortification at MRL level x SDwiR CCß = fortification at MRL x SDwiR

25 Commission Decision 2002/657/EC

26 Commission Decision 2002/657/EC

27 Commission Decision 2002/657/EC

28 Commission Decision 2002/657/EC

29 How to establish CCß … For banned substances CCß = CCa x SDwiR CCa For banned substances CCß = CCa x SDwiR CCa For MRL substances CCß = MRL x SDwiR MRL For MRL substances CCß = MRL x SDwiR MRL

30 For MRL substances CCa = fortification at MRL level x SDwiR CCß = fortification at MRL x SDwiR For MRL substances CCa = fortification at MRL level x SDwiR CCß = fortification at MRL x SDwiR

31 Commission Decision 2002/657/EC

32 Commission Decision 2002/657/EC

33 Commission Decision 2002/657/EC

34 Commission Decision 2002/657/EC

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