Low Lactose ERP - Review Book

4. Does the method, as written, contain all appropriate precautions and warnings related to the method's reagents, components, instrumentation, or method steps that may be hazardous? If no, please suggest wording or option(s). III. Review of Supporting Information 1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc...)? If not, please explain the differences and if the method is impacted by the difference. 2. Is there information demonstrating that the method meets the SMPR Method Performance Requirements using the Reference Materials stated in the SMPR? If not, then specify what is missing and how this impacts demonstration of performance of the method. 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? 3. Is there information demonstrating that the

Yes, all precautions and warnings are met.

All definitions are met, except the units for reconstituted infant formula and liquids are expressed on a volume basis. The current SMPR reports on a mass basis regardless. However, the slight difference in concentration seen between per mass versus volume does not hinder the evaluation against the requirements set forth in the SMPR.

Yes, all data provided meets the SMPR requirements.

Yes, there is sufficient information demonstrating the method performs within the SMPR requirements for lactose.

I could not identify any additional steps that needed further precautionary statements.