2019 Vet Drug Residues ERP - Review Book

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? 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

Yes,

Yes, however as per the SMPR, STC should be 0.5 X MRL where as in the method for most of the compounds STC established lower than MRL values excepts Ex 1) Pyrantel, 2)Flunixin3)Diclofenac4) Carazolol etc. in stream A, and Amoxicillin, Ampicillin, Pencillin G, Cefazolin, Cefoperazone in Stream

Yes, however MRM details along with standard preparation need to be provided for stream A compounds like other streams of the submitted method.

Yes, As per EU CRL guidelines 201/01/2010, one analyte of the stream/ chemical class /family of compounds should be validated before establishing the screening method.

It also require to demonstrate selectivity and detection capability.

Yes,