Food Authenticity NTT SMPR (Comments)

71 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97

6. System Suitability Tests and/or Analytical Quality Control 72 Suitable methods will include blanks, and appropriate check standards.

7. Validation Guidance

a) Data demonstrating method performance is required.

b) Samples: Complete documentation of for the collection and use of authentic samples is must supplied by the method authors. The scope of authentic samples used to construct the “authentic” profile must be applicable to the defined scope of the NTT method. Expansion of the scope is possible with the inclusion of additional authentic samples into the baseline calibration, and validation using the protocol listed in this SMPR. c) For single lab validation studies, the method will be evaluated using prescribed adulterated materials as shown in Table 1. Methods approved at this level will proceed to a second level of evaluation where blinded samples containing unknown adulterants will

be sent to participating laboratories.

d) Methods submitted based on these SMPRs must yield binary analytical results (i.e.

“Authentic” or “Not Authentic”). e) Available guidance documents :

a. AOAC INTERNATIONAL Guidelines for Validation of Botanical Identification Methods, Journal of AOAC International Vol. 95, No. 1, 2012 b. Statistical analysis of interlaboratory studies. LII. Sample size needed to meet performance requirement on proportion.


8. Maximum Time-to-Results


9. Reference Materials 98 A defined set of authentic reference samples is used to construct the “authentic” profile. 99 Detailed protocols used to identify reference materials as authentic and to create adulterated 100 samples must be supplied. 101

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