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March 14, 2017
•
However, when updating the method or for a new analyte, GB will
encourage international literature search; and internationally published or
accepted methods are respected, such as by AOAC.
•
An AOAC adopted method will be the first consideration.
•
Published in Journal of AOAC is the next.
•
If an international standard is adopted, a full Chinese translation is needed.
•
CFSA (China national center for Food Safety risk Assessment) is in charge
of method evaluation.
GB Analytical Methods (3)
6
March 14, 2017
•
Specification
•
LOD
: 3 x SD (blank) or 3 x S/N.
•
Linearity
:
Cover at least 5 concentration points, including LOQ;
Analytical range cover the analytical concentration;
R
2
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•
Accuracy
:
Either: Trueness (known concentration reference standards);
Or 3 levels of spike-recoveries, including LOQ, in sample concentration and highest
concentration with at least 3 replicates for each level.
•
Precision
:
Repeatability, 6 replicates for each concentration level;
Reproducibility, 3 labs other than method submitting lab.
•
Robust
(optional)
•
Uncertainty
(optional)
GB Method Validation Guideline