AOAC SPIFAN Stakeholder Panel Meeting Book (March 14, 2019)

'INOK\KSKTZ͵ Proposal for Evaluation of fitness-for-purpose

߶ӕԙ୆ ۅ չଠऀ ۅ Purpose of the method

ߗ Ӕࣩ㓬ৗ ߗܗ ੌ࠭ Target performance characteristics

ࡌګ ۞੿ Method can be applied

ީ Yes

ސ ࡣ ڐ Շ۪ ސ ࡣ૴ԗ Method development/ adaptation

ेઍԙ୆ ۅ չଠऀ ۅ ީիࢠૡ Fitness-for-purpose

ت ࠢ comparison

ࡄݱ ؅गੜࣩ㓬ৗ ߗܗ Estimated method

ސ ࡣेઍ۪௠ચ Validation/ verification

ի No

performance characteristics

߶ӕ ۅ ਈܶ߶ ੽ ࡌ ेઍ

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'INOK\KSKTZ :KSVRGZK ZU IUSVGXK 53 GTJ -(

Comment leading to result difference

International Official Method (OM)

GB

Method number Analyte Scope Method Principle Regulatory minimum and maximum limits Analysis Technology Calibration curve concentration range Equipment Parameters Calibration Technique Sample weight Sample preparation Procedure Confirmatory steps (micro) Performance characteristics (micro) Final reportable results LOD & LOQ Precison (Repeatbility, Reproducibility) Conclusion:

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