2019 Vet Drug Residues ERP - Review Book

2. Does the analytical technique(s) used in the method meet the SMPR? If not, please specify how it differs from what is stated in the SMPR.

Residue concentration in Matrix N Acceptance Criteria 0 (Blank) 30 ≤10% POD with 95% CL 0.5 MRL 30 per druga ≥ 10% with 95% CL 1.0 MRL 30 per druga ≥ 90% with 95% CL

aTested as drug cocktail(s). bAll incorrect results must be investigated for the determination of the concentration at which POD90 with 95% confidence is achieved.

3. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used. 4. Does the method, as written, contain all appropriate precautions and warnings related to the method's reagents, components, instrumentation, or method steps that may be hazardous? If no, please suggest wording or option(s). III. Review of Supporting Information 1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc...)? If not, please explain the differences and if the method is impacted by the difference. 2. Is there information demonstrating that the method meets the SMPR Method Performance Requirements using the Reference Materials stated in the SMPR? If not, then specify what is missing and how this impacts demonstration of performance of the method.

YES. The terms specified in the SMPR are used and applied appropriately. 32 milk based samples are analyzed for 23 beta lactams, 30-31 samples were analyzed for 23 antimicrobials, 20 samples for HA for 23 antimicrobials. A minimum of 30 replicate samples was to be analyzed for each vet drug. Negative control samples tested negative for the 23 antibiotics Appropriate number of replicate samples used in the estimation of the analytical parameters of the 4 methods

YES

YES. Minor editorial revisions will be provided in the text to the method authors

The SMPR does not require the use of reference standards but the method authors chose to subject the methods to the following Proficiency testing round robins: lyophilized bovine milk, Progetto Trieste 2015, 3rd Round MI1532-2; chicken muscle, Progetto Trieste, 2015, 4th Round, MI 1542-1; lyophilized bovine milk, Progetto Trieste, 2015 4th Round MI 1543-1; lyophilized cod muscle Progetto Trieste 2016, 1st Round FI 1610-2; rabbit muscle, Progetto Trieste 2016, 1st Round M 1625-1; Material B, Salmon muscle RIKILT 2016-02, porcine muscle RIKILT 2017-01, porcine muscle RIKILT 2017-01