7-27-2022_Draft-Agenda -ERP-CASPChemCont Methods

Does the method contain adequate safety precaution references and/or statements?

No

I. Summary of the Method I. Summary of the Method Method itself may be fit for this analysis but supporting data is not satisfactory.

Need re-design study and take sufficient data. II. Review of the Method Only: II. Review of the Method Only 1. Does the applicability of the method support the applicability of the SMPR? If not, please explain what is missing. yes 2. Does the analytical technique(s) used in the method meet the SMPR? If not, please specify how it differs from what is stated in the SMPR. yes 3. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used. yes 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). Method does not written folowing OMA format III. Review of Information in Support of the Method 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. yes 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. No RMs was used. 3. Is there information demonstrating that the 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. No IV. General Submission Package IV. General Submission Package

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