AOAC STANDARDS & METHODS ORIENTATION E-BOOK

9/10/2019

Method Applicability

• Method must be clearly written  in AOAC format – What are the all matrices and/or commodities for which the  method is used should be listed?   • There are times when categories of matrices or  commodities are claimed applicable.  Evidence of this  information should be clearly documented with specifics  commodities evaluated by the method stated in the  method manuscript – Are there specific analytes or limitations for any of the  matrices that an end user will need to know?   • This should be documented also.  Evidence of this  information should be clearly documented in the method  manuscript

Validation Studies for Methods of Analysis

Required  Information for  Method  Evaluation • There are several studies that should be done to characterize the  performance of the method and assess the method’s precision and  consistent capability across multiple laboratories (reproducibility). – Single laboratory validation • Characterizes method performance and assesses method  robustness and repeatability to meet SMPR and/or  guidelines & community expectations – Reproducibility validation  (required for Final Action status) • Characterizes method performance consistency across  multiple method users under reasonable variable  conditions ‐ to meet SMPR and/or guidelines & community  expectations • Multiple approaches to method reproducibility under  consideration

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