Some practical examples of method validation in the analytical laboratory |
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Affiliation: | 1. School of Chemical Engineering, The University of Adelaide, Adelaide, SA 5005, Australia;2. MACRO – the Centre for Macroalgal Resources and Biotechnology, College of Marine and Environmental Sciences, James Cook University, Townsville, Qld 4811, Australia;1. Section of Pediatric Epilepsy, Department of Pediatrics, Rainbow Babies & Children''s Hospital, Cleveland, Ohio, USA;2. Division of Developmental and Behavioral Pediatrics and Psychology, Department of Pediatrics, Rainbow Babies & Children''s Hospital, Cleveland, Ohio, USA;3. Epilepsy Center, Neurological Institute, Department of Neurology, University Hospitals of Cleveland Medical Center, Cleveland, Ohio, USA;4. Department of Pathology, University Hospitals of Cleveland Medical Center, Cleveland, Ohio, USA;5. Department of Neurosurgery, Neurological Institute, University Hospitals of Cleveland Medical Center, Cleveland, Ohio, USA;6. Case Western Reserve University School of Medicine, Cleveland, Ohio, USA;1. Victoria University of Wellington, Wellington, New Zealand;2. Wellington Cardiovascular Research Group, Wellington, New Zealand;3. Malaghan Institute of Medical Research, Wellington, New Zealand;4. University of Otago, Wellington, New Zealand;5. Department of Cardiology, Wellington Hospital, Wellington, New Zealand;1. Departament de Química Física, Universitat de València, C/Dr. Moliner, 50, 46100 Burjassot, València, Spain;2. Sorbonne Universités, UPMC Univ Paris 06, UMR 8235, Laboratoire Interfaces et Systèmes Electrochimiques, F-75005 Paris, France;3. CNRS, UMR 8235, LISE, F-75005 Paris, France |
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Abstract: | Method validation is a key element in both the elaboration of reference methods and the assessment of a laboratory's competence in producing reliable analytical data. Hence, the scope of the term method validation is wide, especially if one bears in mind that there is or at least should be a close relation between validation, calibration and quality control QA/QC. Moreover, validation should include more than the instrumental step only since the whole cycle from sampling to the final analytical result is important in the assessment of the validity of an analytical result. In this article validation is put in the context of the process of producing chemical information. Two cases are presented in more detail: the development of a European standard for chlorophenols and its validation by a full scale collaborative trial, and the intralaboratory validation of a method for ethylenethiourea using alternative analytical techniques. |
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