Abstract
Validation of analytical methods of well-characterised systems, such as are found in the pharmaceutical industry, is based on a series of experimental procedures to establish: selectivity, sensitivity, repeatability, reproducibility, linearity of calibration, detection limit and limit of determination, and robustness. It is argued that these headings become more difficult to apply as the complexity of the analysis increases. Analysis of environmental samples is given as an example. Modern methods of analysis that use arrays of sensors challenge validation. The output may be a classification rather than a concentration of analyte, it may have been established by imprecise methods such as the responses of human taste panels, and the state space of possible responses is too large to cover in any experimental- design procedure. Moreover the process of data analysis may be done by non-linear methods such as neural networks. Validation of systems that rely on computer software is well established. The combination of software validation with validation of the analytical responses of the hardware is the challenge for the analytical chemist. As with validation of automated equipment such as programmable logic controllers in the synthesis of pharmaceuticals, method developers may need to concentrate on the process of validation, as well as the minutiae of what is done.
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References
Wingate GAS (1998) Meas Control 31:5–10
Green JM (1996) Anal Chem 68:305–309A
EURACHEM (1997) Guidance document No. 1/WELAC Guidance document No. WGD 2:Guidance on the interpretation of the EN 45000 series of standards and ISO/IEC Guide 25. Laboratory of the Government Chemist, Teddington, UK
Mulholland MI, Hibbert DB (1997) J Chromatogr 762: 73–82
Food and Drug Administration (1996) Draft guidelines on the validation of analytical procedures: methodology. Federal Register 61:9316–9319
ISO 11095 (1996) Linear calibration using reference materials International Organisation for Standardisation, Geneva
Sargent M (1996) Confidence in Analysis. Laboratory of the Government Chemist, Teddington, UK. VAM Bulletin (Autumn 1996) 3-4
ISO (1995) Guide to the expression of uncertainty in measurement. International Organisation for Standardisation, Geneva
EURACHEM (1995) Quantifying uncertainty in analytical measurement. Laboratory of the Government Chemist, Teddington, UK
McLeod S (ed) (1997) Proceedings of the 14th Australian Symposium on Analytical Chemistry, Adelaide July 1997. Analytical Chemistry Division, Royal Australian Chemical Institute, Melbourne
van Nevel L, Taylor PDP, Örnemark U, Moody JR, Heumann KG, De Bièvre P (1998) Accred Qual Assur 3:56–68
Mulholland MI, Hibbert DB, Haddad PR, Parslov P (1995) Chemometrics Intell Lab Syst 30:117–128
Haswell SJ, Walmsley AD (1991) Anal Proc London 28:115–17
Gardner JW, Bartlett PN (1994) Sens Actuators B 18: 211–20
Hodgins D, Simmonds D (1995) J Autom Chem 17:179–85
Chiba A (1990) Chem Sens Technol 2:1–18
Hierlemann A, Weimar U, Kraus G, Schweizer-Berberich M, Goepel W (1995) Sens Actuators B 26:126–34
Barko G, Papp B, Hlavay J (1995) Talanta 42:475–82
Dickinson TA, White J, Kauer JS, Walt DR (1996) Nature 382:697–700
Hibbert DB (1996) In: Linskens HF, Jackson JF (eds) Modern methods of plant analysis vol 19: Analysis of plant fragrance. Springer, Berlin, pp 119–140
Gardner JW, Bartlett PN (1996) Sens Actuators B 33: 60–67
Martens H, Næs T (1989) Multivariate calibration. Wiley, Chichester, England
ISO 9001 (1994) Quality systems — Model for quality assurance in design, development, production, installation and servicing. International Organisation for Standardisation, Geneva
ISO (1991) Quality management and quality assurance standards — Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software. International Organisation for Standardisation, Geneva
DISC TickIT Office (1995) The Tick-IT Guide: A guide to software quality management system construction and certification. Using ISO 9001: 1994, British Standards Institution, Issue 3, London
Mitchell R, Roscoe S (1998) Meas Control 31:10–13
Coady PJ (1998) Meas Control 31:14–19
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© 1999 Springer-Verlag
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Hibbert, D.B. (1999). Method validation of modern analytical techniques. In: De Bièvre, P., Günzler, H. (eds) Validation in Chemical Measurement. Springer, Berlin, Heidelberg. https://doi.org/10.1007/3-540-27034-5_24
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DOI: https://doi.org/10.1007/3-540-27034-5_24
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