Quant. Micro Working Group Meeting Book (March 11, 2020)

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9. Reference Methods

a. The selection of the appropriate reference method will be determined based on the target analyte and matrix being validated. Examples of acceptable reference methods but not

limited to are:

i. AOAC Official Methods of Analysis

ii. ISO standards

iii. US FDA Bacteriological Analytical Manual (BAM) iv. USDA FSIS Microbiology Laboratory Guidebook (MLG) v. Standard Method for the Examination of Dairy Products (SMEDP) vi. Compendium of Microbiological Methods for the Examination of Foods (CMMEF)

10. Maximum Time-to-Result:

None mandated.

11. References Cited:

a. Appendix F, Official Methods of Analysis of AOAC INTERNATIONAL : AOAC INTERNATIONAL Guidelines for the Development of Standard Method Performance Requirements (2016). b. Appendix J, Official Methods of Analysis of AOAC INTERNATIONAL : AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for Food and

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Environmental Surfaces (2012).

c. Appendix I, Official Methods of Analysis of AOAC International: AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Biological Threat Agent Methods and/or

Procedures (2012).

d. ISO 16140-2:2016 Microbiology of the food chain—Method validation—Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method

e. ISO 16140-1:2016 Microbiology of the food chain—Method validation—Part 1: Vocabulary

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