NDLI: Practical method validation: Validation sufficient for an analysis method

Content Provider	Springer Nature Link
Author	Bruce, P. Minkkinen, P. Riekkola, M. L.
Copyright Year	1998
Abstract	Validation of an analysis method depends on the purpose of the method, the chosen technique and the procedure in question. Methods are used for different research, product development, process control and quality control purposes. The human and economical importance of results vary. Each of the techniques used, such as chromatography-(HPLC, HRGC, TLC), capillary electrophoresis-(CE), spectrophotometry-(UV/VIS, IR, fluorescence, AAS, ICP) or spectrometric techniques (NMR, MS) as well as the hyphenated methods, have their own special features and deficiencies which must be considered. The method can include a simple pretreatment or it may include many demanding steps, it can use automation and data processing in various ways, it can have an official status, it can be a thoroughly verified or less studied one. How should these differences be accounted for during the validation? What would be a sufficient certainty that the method does what is expected, that the method fits for the purpose it was intended?The client (or authority) decides the required timetable, cost and quality level. This is why within a laboratory different quality levels and associated levels of validation exist. This paper tries to outline a practical test frame for validation efforts to assist the analyst when planning validation of a method.
Starting Page	93
Ending Page	106
Page Count	14
File Format	PDF
ISSN	00263672
Journal	Microchimica Acta
Volume Number	128
Issue Number	1-2
e-ISSN	14365073
Language	English
Publisher	Springer-Verlag
Publisher Date	1998-01-01
Publisher Place	Vienna
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	validation precision accuracy linearity limit of detection limit of discrimination limit of determination limit of quantitation repeatability reproducibility ruggedness robustness practicality transferability quality revalidation system suitability Analytical Chemistry Inorganic Chemistry Physical Chemistry Characterization and Evaluation Materials Monitoring/Environmental Analysis/Environmental Ecotoxicology
Content Type	Text
Resource Type	Article
Subject	Analytical Chemistry

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