Low Lactose ERP - Review Book

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.

No.

The method includes one reference standard: MUVA ML-2311. On these bases, the LOQ is calculated. Actually, it appears that specific blanks have not been included. Also, the LOD should be calculated (in the text, LOQ is calculated on the basis of MUVA ML-2011 results; LOD should be mentioned because it is three times standard deviation).

The method system suitability tests and controls (as specified in the SMPR) are fit for purposes. However, it appears that specific blanks have not been included.

Yes, the method is written clearly and concisely. I would only suggest three revisions:

a) The method is considered for lactose, but six sugars are mentioned (and lactose is not analytically considered in all samples). Probably, more emphasis should be shown with reference to lactose only, and with concern to “milk, milk products, and products containing dairy ingredients that are low-lactose or lactose-free” (reference: AOAC SMPR 2018.009). Samples might be variegated

b) The above-mentioned SMPR requires that repeatability is demonstrated; in addition, blanks should be specifically mentioned for controls

c) There are specific references to particular equipment in the text. Could these references be clearly expressed with alternative choices as follows ? “HPLC column, per example ……) OR EQUIVALENT ... " The same thing could be reviewed when speaking of the final summary with relation to column performances: “the …….. column AND EQUIVALENT COLUMNS provide excellent separation…”

In this way, references to specific materials/equipment and equivalent systems would be more evident, even if the section: Equipment states it.

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

Pros/strenghts of the method are surely rapidity and reliability. Also, the method appears user-friendly and easily readable.