2019 Vet Drug Residues ERP - Review Book

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. 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? 3. Is there information demonstrating that the

Every method contains safety precautions section which recommended handling chemicals according to MSDS sheet.

Yes.

Validation for multifamily, aminoglycosides and tetracyclines involved use of incurred samples. Incurred sample was not included for validation of beta lactams, possibly due to availability. During routine analysis, an independent source of verification can be added , if incurred samples are not available.

There are some analytes which have STC set at higher than the lowest MRL. Additionally, comment should be made about the equivalence of validation protocol used by the authors (CRL) to validation guidance in SMPR.

No