Scientific Publications by FDA Staff

J AOAC Int 2013 Jan-Feb;96(1):190-203

Best practices for single-laboratory validation of chemical methods for trace elements in foods. Part I--background and general considerations.

Murphy CJ, MacNeil JD, Capar SG

The metals subgroup of AOAC INTERNATIONAL's Community on Chemical Contaminants and Residues in Food has been engaged for the past several years in discussions concerning the requirements for the single-laboratory validation (SLV) of methods for the determination of trace elements in foods. This paper reviews the general guidance currently available related to validation of chemical analytical methods and current typical validation practices found in publications on the analysis of elements in food and other matrixes, such as environmental and clinical samples. Based on the available guidance on SLV requirements and a review of current practices in elemental analysis, a general approach based on best practices is proposed for SLV of a method for elements in food to demonstrate the method as "fit-for-purpose."