Validation in Chemical Measurement
Paul De Bièvre, Helmut Günzler
Springer Science & Business Media, 2005. gada 12. janv. - 166 lappuses
Validationofmeasurementmethodshasbeenusedforavery ciated measurement uncertainty? The answer must be: no. longtimeinchemistry. Itismostlybasedontheexamination Therecanneverbeamechanismorrecipeforproducing - of a measurement procedure for its characteristics such as tomatically valid results because one can never eliminate precision, accuracy, selectivity, sensitivity, repeatability, re- theskills, theroleandtheresponsibilityoftheanalyst. producibility, detectionlimit, quanti?cationlimitandmore. ISO 9000:2000, item 3. 8. 5 de?nes validation as con?r- When focussing on quality comparability and reliability mation by examination and provision of objective evidence in chemical measurement, the ?elds of interest to this Jour- that the requirements for an intended use are ful?lled . The nal, one stumbles into various interpretations of the term revised edition of the VIM ( VIM3 ), is likely to ?ne-tune validation. It is one more example of a term which is used thisde?nitionoftheconcept validation tobe con?rmation sometimes very consistently, sometimes very loosely or in- through examination of a given item and provision of - deed ambiguously. Since the term is very common in the jective evidence that it ful?lls the requirements for a stated chemical community, it is important that its meaning be intendeduse . nd clear. Turning to the 2 edition of the International Vo- Lookingatsimplepractice, manypeoplearelookingfor cabulary of Basic and General terms in Metrology (VIM) aformaldecisionthatagivenmeasurementmethod automat- (1993), surprisingly we do not ?nd a de?nition. Webster s ically gives them valid i. e. reliable results. One wonders Dictionary of the English language (1992) tells us that val- what this has to do with stated intended use . Reliab- idation is making or being made valid . Obviously valida- ity clearly is a property of a measurement result."
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Citi izdevumi - Skatīt visu
acceptance according accreditation accuracy analysis analytical application approach assessment associated bias calculated calibration capillary certified chemical chemistry clinical compared comparison complete components concentration confidence corrosion criteria CRMs defined definition described detailed detection determination direct discussed documentation drug effect equipment established estimation evaluation example experimental experiments factors functions given Guide HPLC important indicated injection installation intended International laboratory limit linearity manufacturers matrix mean measurement measurement uncertainty ment method validation necessary obtained official operating parameters peak performance phase possible practice precision prepared present procedure protocol qualification quality assurance range recovery reference materials reliability repeatability reproducibility requirements response routine sample scope selectivity solution solvent sources specifications standard steps Table test methods tion uncertainty variation vendor verification