Low Lactose ERP - Review Book

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.

Check standard data is tabulated in Appendix E (additional columns indicating the deviation from target would be nice to add). The data from blanks are not recorded, but it is mentioned in the text that they are blank.

No the method is not clearly nor concisely reported. Information for the method is mixed with information for the validation. Likewise a lot of unnecessary "marketing" information appears to be included in the method. Suggest removing anything in excess of what the user needs to know to execute the method successfully.

Section G(d) Inline dialysis parameters has many mistakes that need to be adressed. E.g. ...."is run with a fixed dialysis time and varying dialysis times"

Section G(d) states "controls of the setup should be run periodically". The timing needs to be better defined.

Figure 3 is not clear. Would be better if the X- axes on the two upper graphs were labelled with "dialysis time" and "transfer time" rather than "number"

Section J(b) the legend for the equation does not match what is written in the equation

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

- the in-line dialysis appears to be a good approach for simplifying sample preparation.

- the tests done so far indicate lactose is well separated from potential interfering substances, but this needs to be confirmed by exposing the method to a broader scope of matrices.

6. Based on the supporting information, what are the cons/weaknesses of the method?

major issue at the moment is that there is insufficient data to asess method performance.

LoD / LoQ might be an issue - to be assessed