2019 Vet Drug Residues ERP - Review Book

3. Is there information demonstrating that the

YES

method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. IV. General Submission Package 1. Based on the supporting information, were there any additional steps in the evaluation of the method that indicated the need for any additional precautionary statements in the method? 2. Does the method contain system suitability tests or controls as specified by the SMPR? If not, please indicate if there is a need for such tests or controls and which ones. 3. Is there information demonstrating that the method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify. 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. 5. Based on the supporting information, what are the pros/strengths of the method?

NO

YES

YES

Except for a few typographical and editorial errors, the method was written clearly and concisely. Recommendations for minimum editorial revision

1. Methods have the capacity and ability to screen for the presence and or absence of the specifiedd beta-lactams in the specified matrices. 2. For the aminoglycosides, Gentamicin monitored as sum of C1, C1a, C2, C2a; 3. Protonated ion and at least 1 transition ion but no identification ion and retention time provided for each aminoglycoside vet drug 4. For the beta-lactams monitoring cephapirin as desacetyl cephapirin 5. Ionization and retention parameters for the beta lactams provide for guidance 6. A minimum of 60 samples analyzed in replication for repeatability assessment