Best Practices for Single-Laboratory Validation of Chemical Methods for Trace Elements in Foods. Part I—Background and General Considerations

Author:

Murphy Cory J1,MacNeil James D1,Capar Stephen G2

Affiliation:

1. Canadian Food Inspection Agency, Dartmouth Laboratory, 1992 Agency Drive, Dartmouth, Nova Scotia, Canada, B3B 1Y9

2. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Offce of Regulatory Science, Division of Bioanalytical Chemistry, 5100 Paint Branch Pkwy, College Park, MD 20740

Abstract

Abstract 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.”

Publisher

Oxford University Press (OUP)

Subject

Pharmacology,Agronomy and Crop Science,Environmental Chemistry,Food Science,Analytical Chemistry

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