SPDS EXPERT REVIEW PANEL

C. Is there information demonstrating that the

YES: There are information demonstrating that the method performs within the SMPR Method Performance Requirements table specifications for all analytes in the SPMR applicability statement.

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. A. 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? B. 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. C. 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.

IV. General Submission Package

In my opinion there is no need.

YES: There are.

YES: There are information demonstrating that the method system suitability tests and control as specified in the SMPR worked appropriately and expected.