Low Lactose ERP - Review Book

3. Is there information demonstrating that the

Repeatability on different matrices are within 10%. The samples include UHT milk, sugary plain yogurt, flavoured plain yogurt, Greek yogurt, flavoured liquid yogurt, chocolate milk, cream, soft cheese, infant formula, café late, high protein vanilla shake. Recovery on lactose was evaluated in spiking experiment. The results are good. LOD/LOQ results are good. ML harmonization materials were measured, but recovery was not calculated. Recovery in each concentration range, especially the low lactose range 5-100 mg/100g, should be evaluated with reference materials.

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

None

The SMPR requires blanks and check standards. The method specifies that every 10-15 measurements or after the device has not been running for a minimum of 30 min, the operator need to do a Standard measurement, which serves as a check standard.

It is a proprietary method. All the calibration and check are done internally. There is no raw data available to assess whether the system suitability tests are adequate or not.

The description of the method is clear. Note: the g.3 section is not clearly marked.

The strengths of this method include: No sample extraction and filtration needed as compare to other chromatographic method; No mobile phases, no data process, the concentration result is directly given by the device after the measurement.