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Guidelines on Validation of Non-Regulatory Chemical and Radiochemical Methods
Citation:
Griggs, J., A. Mudambi, W. Adams, S. Blaze, M. StGermain, J. Gundersen, A. Hanley, K. McCroan, B. Pepich, Y. Qian, R. Segall, K. Thomas, C. Cook, AND T. Strock. Guidelines on Validation of Non-Regulatory Chemical and Radiochemical Methods. U.S. Environmental Protection Agency, Washington, DC, EPA/600/B-22/001, 2022.
Impact/Purpose:
The purpose of this document is to provide a consistent general approach for the validation of newly developed, adopted (e.g., from another agency, voluntary consensus standard development body such as ASTM International, not previously validated, etc.), or modified chemical and radiochemical methods for non-regulatory purposes. This document is intended for use by internal EPA personnel engaged in method validation activities, and for the understanding of those who use EPA methods. This document can also be used by external bodies (e.g., private and state laboratories, voluntary consensus standard bodies, etc.) engaged in method validation efforts.
Description:
This document provides collected information on critical areas of method performance assessment for validation studies. This document introduces the following new concepts: 1) Lifecycle of a method, which identifies the typical activities a method goes through during its development and use. 2) Validation Design, which is a short descriptor indicating the number of laboratories and matrices in a validation study. 3) Method Validation Summary, which is designed to provide consistency in delivery of summary method validation results in a concise, easy-to-prepare and share format.