AOAC-RI ERP Book MICRO Sept 2016.pdf

9/2/2016

OMB Expectation Parameters

Method Applicability

Safety Concerns

Reference Materials

Safety review needed prior to First Action status All concerns must be addressed within tracking period

Must be clearly written and meet user needs

Source reference materials

ERP recommendations implemented

Alternatives if none available?

Assess method limitations and concerns

OMB Expectation Parameters

Comparison to Standard/ Acceptance Criteria

Single Laboratory Validation

Reproducibility/ Uncertainty

Documented method performance versus a SMPR, recognized reference standard (materials), recognized reference method, or general method end user community guidance and/or acceptance criteria

Qualitative methods: inclusivity (or equivalent), exclusivity (or equivalent), robustness, repeatability, POD (or equivalent), cross reactivity, matrix scope, etc…

Qualitative methods: - probabilityof detection or equivalent

Quantitative methods: demonstrated method linearity, accuracy, repeatability, selectivity, LOD/LOQ, Matrix scope, etc….

Quantitative methods: demonstrated method reproducibilityand/or uncertainty

Document reasons for acceptability if it doesn’t meet the standard or acceptance criteria

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