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  • Author: Roger Wood x
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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.

The international standardizing organizations - International, ISO, and IUPAC - cooperated to produce the International Harmonized Protocol for the Proficiency Testing of (Chemical) Analytical Laboratories. The Working Group that produced the protocol agreed to revise that Protocol in the light of recent developments and the experience gained since it was first published. This revision has been prepared and agreed upon in the light of comments received following open consultation.

Synopsis: ISO, IUPAC and AOAC INTERNATIONAL have co-operated 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] and on "Internal Quality Control in Analytical Chemistry Laboratories" [3]. The Working Group that produced these protocols/guidelines was asked to prepare guidelines on the use of recovery information in analytical measurement. Such guidelines would have to outline minimum recommendations to laboratories producing analytical data on the internal quality control procedures to be employed.

A draft of the guidelines was discussed at the Seventh International Symposium on the Harmonization of Quality Assurance Systems in Chemical Laboratory, sponsored by IUPAC/ISO/AOAC INTERNATIONAL, held in Orlando, USA, 4-5 September 1996. Proceedings from that Symposium are available [4].

The purpose of these guidelines is to outline the conceptual framework needed for considering those types of analysis where loss of analyte during the analytical procedure is inevitable. Certain questions cannot be satisfactorily addressed, and hence remain irreducibly complex, unless such a conceptual framework is established. The questions at issue involve (a) the validity of methods for estimating the recovery of the analyte from the matrix of the test material, and (b) whether the recovery estimate should be used to correct the raw data to produce the test result. The types of chemical analysis most affected by these considerations are those where an organic analyte is present at very low concentrations in a complex matrix.