OMB Meeting Book (June 25-26, 2015)

Furthermore, during this meeting the SPIFAN Working Group on SPIFAN Matrices presented a list of 1 testing materials that would be donated by the infant formula manufacturers, characterized, and 2 stored 5 . See appendices – SPIFAN product matrices and SPIFAN SLV Kit 6 . 3 4 B. Guidance and support can be obtained from the AOAC Technical Division on Reference Materials. 5 6 As part of the development of the SMPRs, AOAC has added a document from the AOAC Technical 7 Division on Reference Materials (TDRM) at the request of TDRM, to the SMPR guidelines 7 (OMA 8 Appendix F). AOAC OMB has reviewed this information prior to its publication in the OMA. 9 10 SINGLE LABORATORY VALIDATION: 11 A. Data demonstrating Response Linearity, Accuracy, Repeatability, LOD/LOQ, and Matrix Scope must 12 be present. Experimental designs to collect this data may vary with the method protocol and the 13 intended use of the method. 14 15 The ERP reviewed two papers 8,9 one of which included a single laboratory validation (SLV) for AOAC 16 2012.16. This information along with the method evaluation form was then used to confirm that this 17 method would move forward towards Final Action recommendation with the inclusion of a 18 reproducibility evaluation. Additionally, the SPIFAN SLV Guidelines 10 was prepared by a group chair by 19 Norma Hill and discussed in a Study Directors Education Session 11 in April 2011. The final version of the 20 guidelines was refined during September 2011 ERP meeting. 21 22 B. Resources can be identified by the AOAC Committee on Statistics.

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5 AOAC SPIFAN Meeting Minutes from AOAC SPIFAN meeting held on April 5, 2011 (Day 1 of AOAC SPIFAN meeting) 6 SPIFAN Single Laboratory Validation Kit – Common infant formula reference materials. 7 Appendix F: Guidelines for Standard Method Performance Requirements Official Methods of Analysis of AOAC INTERNATIONAL e-OMA at www.aoac.org . 8 Andrieux et. al., Pantothenic Acid (Vitamin B5) in Infant Formula and Adult/Pediatric Nutritional Formula: First Action 2012.16 9 Andrieux et al., Pantothenic Acid (Vitamin B5) in Fortified Foods: Comparison of a Novel Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry Method and a Microbiological Assay (AOAC Official Method SM 992.07) 10 Appendix L: AOAC Recommended Guidelines for Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Single- Laboratory Validation , 11 AOAC SPIFAN Study Directors Education Session Meeting Minutes held on April 4, 2011.

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