ISPAM Stakeholder Panel Meeting Book 3-14-17

91 92 93 94 95 96 97 98 99

8. Validation Guidance :

Method developers must provide data for method performance in all the claimed matrices.

Method developers must provide recovery data using incurred samples for all claimed

matrices.

Add appropriate Appendix reference for PTM requirement (Appendix J).

Appendix D : Guidelines for Collaborative Study Procedures To Validate Characteristics of a Method of Analysis ; 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis

100 101 102 103 104 105 106 107 108 109 110 111 112 113

(2012). Available at: http://www.eoma.aoac.org/app_d.pdf

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

Appendix M : Validation Procedures for Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices; 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at: http://www.eoma.aoac.org/app_m.pdf

Table 1: Method performance requirements (deleted wine section)

Parameter

Minimum Acceptance Criteria for target matrix

Analytical Range (ppm)

≤ 5 - ≥ 10

LOQ (ppm)

≤5

LOD (ppm)

≤5

50-150%

Recovery (%)*

% RSD r

≤20 %

% RSD

≤ 30%

R

Note: ppm dried egg. *Using incurred samples (acceptance criteria in Appendix M).

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