Title: Method Validation and Reference Materials
Authors: BELLOCCHI GianniBERTHEAU YvesDE GIACOMO MarziaHOLST-JENSEN ArneMACARTHUR RoyMAZZARA MarcoONORI RobertaTAVERNIERS IsabelVAN DEN BULCKE MarcTRAPMANN Stefanie
Publisher: Blackwell Publishing Limited
Publication Year: 2013
JRC N°: JRC85060
ISBN: 9781444337785
9781118373781
URI: http://onlinelibrary.wiley.com/book/10.1002/9781118373781;jsessionid=7F97685EC403B87F84BB6EF21F8B1DAD.f03t01
http://publications.jrc.ec.europa.eu/repository/handle/JRC85060
DOI: 10.1002/9781118373781
Type: Articles in periodicals and books
Abstract: The producer of analytical results must ensure that these results are reliable and also that they have all the elements necessary for the user to feel confi dent in them. This is because analytical information can be used for a variety of purposes: to make decisions involving the control of the manufacturing process of a product, to assess whether a product complies with regulatory limits, and to make decisions about legal affairs, international trade, health problems or the environment. Procedures to improve the objectiveness of validation procedures must be introduced and adopted. Such limitations to current validation practices were recently outlined by the Molecular Biology and Genomics Unit (European Commission Joint Research Centre, Ispra, Italy), who advocate the use of fuzzy - logic based indicators for interpretation of validation results (Bellocchi et al., 2006, 2008, 2010a ). This approach has been implemented within the European research project Co - Extra for validating innovative methods such as array analysis and for providing a proof of concept for modular validation of analytical methods. In this chapter we will describe all of these validation techniques and associated issues, as well as an additional approach to combining validation statistics using uncertainty profi les.
JRC Directorate:Institute for Health and Consumer Protection Historical Collection

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