Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report)

TLDR

Method validation is universally recognized as a necessary part of a comprehensive quality assurance system in analytical chemistry, and past collaborations among ISO, IUPAC, AOAC, and others have produced guidelines on method performance studies, proficiency testing, internal quality control, and recovery information. The IUPAC Working Group has been tasked to prepare guidelines for single‑laboratory validation of analytical methods. The guidelines recommend minimum procedures to ensure adequate validation of analytical methods. A draft of the guidelines was discussed at an International Symposium on the Harmonization of Quality Assurance Systems in Chemical Laboratory, with proceedings published by the UK Royal Society of Chemistry.

Abstract

Abstract Method validation is one of the measures universally recognized as a necessary part of a comprehensive system of quality assurance in analytical chemistry. In the past, ISO, IUPAC, and AOAC International have cooperated to produce agreed protocols or guidelines on the "Design, conduct and interpretation of method performance studies" [1], on the "Proficiency testing of (chemical) analytical laboratories" [2], on "Internal quality control in analytical chemistry laboratories" [3], and on "The use of recovery information in analytical measurement" [4]. The Working Group that produced these protocols/guidelines has now been mandated by IUPAC to prepare guidelines on the single-laboratory validation of methods of analysis. These guidelines provide minimum recommendations on procedures that should be employed to ensure adequate validation of analytical methods. A draft of the guidelines has been discussed at an International Symposium on the Harmonization of Quality Assurance Systems in Chemical Laboratory, the proceedings from which have been published by the UK Royal Society of Chemistry.