Allergens ERP Book, Sept 17

OMB Expectation Parameters

Method  Applicability

Safety  Concerns

Reference  Materials

Must be clearly  written and meet  user needs

Safety review  needed prior to  First Action status

Source reference  materials

All concerns must  be addressed  within tracking  period

ERP  recommendations implemented

Alternatives if  none available?

Assess method  limitations and  concerns

OMB Expectation Parameters

Comparison to  / Standard  Acceptance Criteria

Single Laboratory

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: ‐ probability  of detection or equivalent

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

Quantitative methods:   demonstrated method  reproducibility and/or uncertainty

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

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