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?

Yes

Yes

Yes

-LC/MS ensures high degree of selectivity and sensitivity. -Different work streams offer optimal performance for a variety of compounds with different physicochemical properties. -Each sample is analyzed twice to demonstrate absence of analyte in the unspiked sample and presence of analyte after spiking. -Design of validation scheme using cutoff value is original, sound, and effective. -Extensive use of blanks, positive controls, negative controls, and proficiency test samples greatly enhance confidence in generated results.

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

-3 compounds had to be removed from the scope of the method. If these are to be included, additional work streams will have to be developed.

7. Any general comments about the method?

The method is of high quality, scientifically sound, and properly validated.

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.

Yes, I recommend the method as a First Action. It meets or exceeds the SMPR for the vast majority of compounds.