3. Choose validation materials and set their reference values
At least three materials with known contents are required for testing. According to NF EN ISO/CEI 17025 – General requirements for the competence of testing and calibration laboratories, there are four types, depending on the method to be validated:
methods for which MRCs are available;
methods for which a reference method exists ;
methods for which proficiency tests are organized and MREs are available;
other methods for which none of the above solutions is available.
With the example given, it would be possible to use proposition 2, since an official method exists. Nicotinamide is commercially available in known purity (95%). To obtain known concentration levels, the dosed addition method was preferred....
The Ultimate Scientific and Technical Reference
This article is included in
Laboratory quality and safety procedures
This offer includes:
Knowledge Base
Updated and enriched with articles validated by our scientific committees
Services
A set of exclusive tools to complement the resources
Practical Path
Operational and didactic, to guarantee the acquisition of transversal skills
Doc & Quiz
Interactive articles with quizzes, for constructive reading
Choose validation materials and set their reference values
Organize the validation and calibration experimental plans
Bibliography
Collège Français de Métrologie: Application of the new VIM3 calibration concept (Reissued 2014)
Commission Decision of August 12, 2002 implementing Council Directive 96/23/EC as regards the performance of analytical methods and the interpretation of results (2002/657/EC)
Feinberg (M.), Labo-Stat: Guide de validation des méthodes d'analyse...
Normative references
ISO 16140: 2003 Microbiology of food: validation protocol for alternative methods (2003) ISO, Geneva
NF EN ISO/CEI 17025 : 2005 General requirements for the competence of testing and calibration laboratories (2005) ISO, Geneva
NF V03-110 (May 2010) Analysis of agricultural and food products – Characterization protocol for the validation of a quantitative analysis method...
Websites
Arlenda is a bio-statistics consultancy that has developed software for validating analytical methods.
This site offers commercial software for validating analytical methods.
The Ultimate Scientific and Technical Reference
