2019 Vet Drug Residues ERP - Review Book

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?

Blank checks and check standards were part of method validation.Cutoff determination calculations were provided.

Required data is provided to prove that the system suitability tests and controls worked as specified in SMPR.

Yes.

Based on the data provided, method is rugged and easy. Dividing veterinary drugs into different groups add more reliability to analysis especially for challenging groups such as aminoglycosides and beta lactams. Method is organized and very detailed. It includes specific handling directions for certain group of analytes that could significantly affect the outcome. Since naturally incurred samples/CRM are difficult o find for all/majority of veterinary drugs, an independent source of verification should be added during routine analysis.

6. Based on the supporting information, what are the cons/weaknesses of the method?

7. Any general comments about the method?

None.

V. Final Recommendation Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? Please specify rationale.

I am convinced by the method's ability to screen and identify drug residues in assorted matrices discussed in the document. Proposed method meets the SMPR requirements. Method is technically sound and rugged.