2018 August 26 SPSFAM Book

Table 1. Method Performance Requirements

Residue Concentration  in Matrix

N Acceptance Criterion

0 (blank)

30 ≤10% POD with 95%  confidence

≤  (or ≥ 90%) 10% POD  with 95% confidence ≥90% POD with 95%  confidence b

0.5x MRL

30 per  drug a 30 per  drug a

1.0x MRL

a Tested as drug cocktail(s). b All incorrect results must be investigated for the determination of the concentration at which POD 90 with 95% confidence is achieved.

System suitability tests and/or analytical quality  control: • Suitable methods will include blank  check samples and check standards at  0.5 x MRL and 1.0 x MRL. 

• Method developers will provide  information on how cutoffs were  determined. • Method developers may prepare  cocktails of multiple drug residues.