2018 - March 12 SPSFAM Meeting Book

7. Validation Guidance 77 Method data packages must include performance data covering the method claimed 78 matrices. A useful tool can be found in food pyramid concept described in Annex F of 79 Appendix F the AOAC Official Methods of Analysis. Matrix variations in non-sugar 80 carbohydrate and moisture content must be investigated and data provided. For 81 example, using the food pyramid in sector 7, a matrix may be either high in sugar or high 82 in non-sugar carbohydrates (e.g., starch, sugar alcohols), each of which may affect 83 method performance. 84 Method data packages must include relevant data regarding interferences and 85 instabilities, such as listed in Table 2. Data packages must include data to demonstrate 86 that the sugar composition in the extract is a representation of the true sugar 87 composition in the food product and assess the stability of extracts over the duration of 88 the test. 89 8. Reference materials

90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112

Refer to Annex F: Development and Use of In-House Reference Materials in Appendix F : Guidelines for Standard Method Performance Requirements , 19 th Edition of the AOAC

INTERNATIONAL Official Methods of Analysis (2012). Available at:

http://www.eoma.aoac.org/app_f.pdf

Potential reference materials, depending on method scope, may include the following:

NIST 3233 – Breakfast cereal NIST 2383A – Baby Food

NIST 3282 – Juice

NIST 1849A – Infant Formula IRMM BCR644 – Artificial foodstuff

SRM 2384 (SC to reach out to NIST)

9. Maximum Time-to-Results

None.

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