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Validation in Chemical Measurement

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Erschienen am 06.12.2005, Auflage: 1/2005
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Bibliografische Daten
ISBN/EAN: 9783540270348
Sprache: Englisch
Umfang: 168 S., 2.32 MB
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Format: PDF
DRM: Digitales Wasserzeichen

Beschreibung

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?nitionoftheconceptvalidationtobecon?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. Websters 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.

Inhalt

P. De Bièvre: Editorial/Introduction to this volume.- F.T. Peters, H.H. Maurer: Bioanalytical method validation and its implications for forensic and clinical toxicology A review.- I. Kuselman, B. Anisimov, A. Shenhar, A. Lepek: Validation of a computer program for atomic absorption analysis.- G.A. Ross: Instrumental validation in capillary electrophoresis and checkpoints for method validation.- L. Huber, H. Wiederoder: Qualification and validation of software and computer systems in laboratories. Part 1.- M. Buzoianu, H.Y. Aboul-Enein: Clinical reference materials for the validation of the performance of photometric systems used for clinical analyses.- St. L.R. Ellison, A. Williams: Measurement uncertainty and its implications for collaborative study method validation and method performance parameters.- L. Huber: Qualification and validation of software and computer systems in laboratories, Part 2.- L. Huber: Qualification and validation of software and computer systems in laboratories, Part 3.- L. Huber: Qualification and validation of software and computer systems in laboratories, Part 4.- S. Seno, S. Ohtake, H. Kohno: Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry.- R. Bettencourt, da Silva et al.: Validation of the uncertainty evaluation for the determination of metals in solid samples by atomic spectrometry.- R.J. Wells: Validation requirements for chemical methods in quantitative analysis, horses for courses?.- R.J. Wells: Validation requirements for chemical methods in quantitative analysis, horses for courses?.- Stefan, Aboul-Enein: Validation criteria for developing ion selective membrane electrode for analysis of pharmaceuticals.- S. Küppers: Is the estimation of measurement uncertainty a viable alternative to validation?.- R.C. Diaz et al.: Validation of an HPLC method for the determination of p-dichlorobenzene and naphthalene in mothrepellents.- V.J. Barwick et al.: The evaluationof measurement uncertainty from method validation studies, Part 1.- V.J. Barwick et al: The evaluation of measurement uncertainty from method validation studies, Part 2.- S. Linko: Automated ion selective measurement of lithium in serum. A practical approach to result-level verification in a two-way method validation.- P. Woitke et al.: Determination of Hydrocarbons in Water Interlaboratory Method Validation prior routine monitoring.- G. Anand Kumar, G. Swarnabala et al.: Interlaboratory quality audit program for potable water Assessment of method validation done on ICP-OES.- N. Majcen: A need for clearer terminology and guidance in the role of reference materials in method development and validation.- E. Ramoskiene et al.: Validation of salt spray corrosion test.- M. Lauwaars, E. Anklam: Method validation and reference materials.- B. Hibbert: Method validation of modern analytical techniques.- M. Holmgren: Validation of test methods General principles and concepts.- A. Gillespie: Marketing valid analytical measurement.- R. Kadis: Analytical procedure in terms of measurement (quality) assurance.- A. Leclerq: Flexibilisation of the scope of accreditation: an important asset for food and water microbiology laboratories.- H. Hey: Legal requirements on validation of test methods for official control of foodstuffs, veterinary drug residues and element contaminants in the EC.- M. Lauwaars: Methods validation AOACs three validation systems.- M. Holmgren: Observing validation, uncertainty determination and traceability in developing Nordtest test methods.

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