OMB Meeting Book (June 22, 2017)

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ERP SUMMARY FOR FIRST TO FINAL ACTION METHOD RECOMMENDATION

AOAC 2016.05 

Analysis of Vitamin D2 and Vitamin D3 by LC MS/MS in Milk Powders, Infant  Formulas, and Adult Nutritionals 

GUIDANCE FOR AOAC ERPS ‐ APPENDIX G 1 Considered? Comments/Reference if applicable Method Applicability  Yes  Meets SMPR  ERP First Action to Final Action  recommendations & improvements  Yes  Draft Final Action method reviewed by ERP Yes  Completed in June 2017  Safety Concerns  Yes  ReferenceMaterials  Yes  NIST 1849a and SPIFAN Materials  Single Laboratory Validation  Yes 

Gill et al, Journal of AOAC Int 99, 5 (2016) p.1321 

Reproducibility/Uncertaintyand  Probability of Detection 

In publication pending review. 

Yes 

AOAC 2011.004  All Addressed 

Comparison to SMPR ( SMPR criteria met?)

Yes  Yes 

Feedback from Users of Method 

Comments

DOCUMENTATION Safety Evaluation  ReferenceMaterials 

Available?

Yes  Yes  Yes  Yes  Yes  Yes  Yes  Yes  Yes  Yes 

NIST 1849a and SPIFAN Materials 

  Gill et al, Journal of AOAC Int 99, 5 (2016) p.1321 

SLV or PTM 

OMA Appendix L 

Approved Validation Protocols  Statistics Review  Method Published in OMA 

Meets the AOAC SMPR 2011.004 

Method Performance vs SMPR criteria 

All addressed 

Feedback Information  Additional Recognition(s) 

 Is a working item in ISO 

3‐16‐2016; 9‐20‐2016; 3‐16‐2017 

ERP Reports 

Gill et al, Journal of AOAC Int 99, 5 (2016) p.1321  (SLV); MLT publication in process 

Manuscript(s) Published in JAOAC 

ERP Method Recommendation   (Final Action/Repeal/Continuation) 

1 Official Methods of Analysis of AOAC INTERNATIONAL , Appendix G: Procedures and Guidelines for the Use of AOAC Voluntary Consensus Standards  to Evaluate Characteristics of a Method of Analysis, p.3 “ First Action to Final Action Methods: Guidance for AOAC Expert Review Panels.”