Low Lactose ERP - Review Book

3. Is there information demonstrating that the

The method meets the lactose specified SMPR requirements.

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.

No additional steps recommended.

Recommended peak resolutions for potential conflicting compounds are listed to assess chromatographic separations. This is also listed as a tool to adjust chromatographic conditions to attain proper peak separations.

The method validation included an in-depth robustness study to assess method performance. The controls and suitability parameters in the method are acceptable.

1) The extraction protocol must be corrected for the extraction solution being used (water or water-ethanol). 2) One step is listed as adding lactose to one of the 2 subsamples. If this is to assess enzyme performance, it should be stated in the method along with acceptance criteria. 3) There may be some Eurofins' nomenclature in the submitted method (such as PD5954 Procedure for the handling of control charts). These should be removed. 4) The validation raw data was not easy to decipher given the verbiage. This should be clarified especially for the LOD determination. Method can measure low levels of lactose with an LOD that can be used to declare a food as lactose free. Potential co-eluting interferences are negated using the the difefrence between 2 subsamples with one subsample enzymatically removing lactose prior to measurement.

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