Validation in Chemical Measurement

Pirmais vāks
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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Bioanalytical method validation and its implications for forensic and clinical toxicology A review
1
Validation of a computer program for atomic absorption analysis
10
Instrumental validation in capillary electrophoresis and checkpoints for method validation
14
Part 1 Validation during development
24
Clinical reference materials for the validation of the performance of photometric systems used for clinical analyses
31
Measurement uncertainty and its implications for collaborative study method validation and method performance parameters
37
Part 2 Qualification of vendors
42
Part 3 Installation and operational qualification
46
Part 2 The practical application of a laboratory protocol
91
Automated ionselective measurement of lithium in serum A practical approach to resultlevel verification in a twoway method validation
101
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107
Interlaboratory quality audit program for potable water assessment of method validation done on inductively coupled plasma atomic emission spectr...
112
A need for clearer terminology and guidance in the role of reference materials in method development and validation
116
Validation of salt spray corrosion test
121
Method validation and reference materials
128
Method validation of modern analytical techniques
134

Part 4 Evaluation and validation of existing systems
51
Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry
56
Validation of the uncertainty evaluation for the determination of metals in solid samples by atomic spectrometry
62
Validation requirements for chemical methods in quantitative analysis horses for courses?
68
Validation criteria for developing ionselective membrane electrodes for analysis of Pharmaceuticals
73
Is the estimation of measurement uncertainty a viable alternative to validation?
76
Validation of an HPLC method for the determination of pdichlorobenzene and naphthalene in mothrepellents
80
Part 1 Description of a laboratory protocol
84
General principles and concepts
139
Marketing Valid Analytical Measurement
143
Analytical procedure in terms of measurement quality assurance
148
an important asset for food and water microbiology laboratories
153
Different approaches to legal requirements on validation of test methods for official control of foodstuffs and of veterinary drug residues and elemen...
159
AOACs three validation systems
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Observing validation uncertainty determination and traceability in developing Nordtest test methods
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