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Page Background http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/F

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oodProcessingHACCP/ucm073110.htm

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6.

Doyle ME, Mazzotta AS, Wang T, Wiseman DW, and Scott VN. 2001. Heat resistance of

3

Listeria monocytogenes

.

Journal of Food Protection

64 (3): 410-429.

4

7.

ISO 18593. Microbiology of food and animal feeding stuffs – Horizontal methods for

5

sampling techniques from surfaces using contact plates and swabs.

6

7

8.

AOAC Research Institute

Performance Tested Methods

SM

Program

validation outline

8

protocol:

Comparative Evaluation of the 3M

Molecular Detection Assay Listeria

9

monocytogenes 2 and of the 3M

Molecular Detection Assay Listeria

2 (February 2015)

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11

9.

ISO 16140:2003. Microbiology of food and animal feeding stuffs – Protocol for the

12

validation of alternative methods.

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14

10. U. S. Food and Drug Administration

Bacteriological Analytical Manual

, Chapter 3

Aerobic

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Plate Count (

January 2001) (Accessed January 2015)

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http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm063346.m

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11. Least Cost Formulations, Ltd., MPN Calculator Version 1.6

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www.lcfltd.com/customer/LCFMPNCalculator.exe

(Accessed January 2015)

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12. AOAC International,

Evaluation of the

VITEK 2

Gram Positive (GP) Microbial

22

Identification Test Card: Collaborative Study

, Journal of AOAC International, 95, 1425

23

(2012)

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25

13. Wehling, P., LaBudde, R., Brunelle, S., Nelson, M.

Probability of Detection (POD) as a

26

Statistical Model for the Validation of Qualitative Methods.

Journal of AOAC

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International, Vol. 94, No. 1, 2011.

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29

14. Least Cost Formulations, Ltd., AOAC Binary Data Interlaboratory Study Workbook Version

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2.2 (2011)

-http://lcfltd.com/aoac/aoac-binary-v2-2.xls(

Accessed January 2015)

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15. Official Methods of Analysis of AOAC INTERNATIONAL (2012) 19th Ed., Appendix J:

33

AOAC INTERNATIONAL Methods Committee Guidelines for Validation of

34

Microbiological Methods for Food and Environmental Surfaces, AOAC INTERNATIONAL,

35

Gaithersburg, MD,

36

http://www.aoac.org/imis15_prod/AOAC_Docs/StandardsDevelopment/eoma_appendix_j.pdf

(Accessed

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January 2015)

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39

40

AOA

C Research Institute

E

xpert Review Panel Use Only

OMAMAN-29 D/ PTM Validation Report 111501

OMA ERP - June 2016

ERP Use Only