Low Lactose ERP - Review Book

3. Is there information demonstrating that the

The lactose is the only analyte applicable in this case but the specificity of the analyte in presence of potential interference is not fully demonstrated.

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 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.

The carryover / retention risk of the Patented Stopped-Flow Dialysis system is not demonstrated for various matrices. This is very important food safety consideration as the system is meant to measure low level lactose and / or lactose free products.

Selectivity did not include blanks at all. Ideally a high-level lactose product followed by a placebo and reagent blanks to demonstrate the specificity of the system overall.

MUVA and NIST reference results are within the certified limits.

The method is clearly written, the procedure is clear and apparatus & materials, reagents are very well documented. The results and summary sections are poorly articulated. The method and validation reports are to be well separated. The validation exercise to aligned to AOAC guidelines and to be followed in terms of performance evaluation procedures and replicate requirements. Summary section should conclude the findings and how it conforms to SMPR applicability and performance requirements. The data should be presented in clearly titled tables for easy overview and evaluation purposes.

5. Based on the supporting information, what are the pros/strengths of the method?

The method procedure is clearly written especially the materials and methods section instrumentation.