Validation in Chemical MeasurementPaul 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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Saturs
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 |
Determination of hydrocarbons in waterinterlaboratory method validation before routine monitoring | 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 | 163 |
Observing validation uncertainty determination and traceability in developing Nordtest test methods | |
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acceptance Accred Qual Assur accuracy Anal analysis analyte concentration analytical chemistry analytical measurement analytical method analytical procedure Anklam AOAC AOAC INTERNATIONAL application application software assessment bias calculated calibration curve capillary cation certified reference materials chemical clinical components computer systems corrosion criteria defined detector determination documentation drug EURACHEM evaluation experimental factors functions Hewlett-Packard HPLC injection installation instrument interlaboratory International laboratory linearity LLOQ matrix measurement uncertainty ment meth method validation Metrology mmol/l obtained operating parameters peak performance pharmaceutical phase precision protocol qualification quality assurance quantitative quinizarin range recovery reference materials relative standard deviation reproducibility requirements routine ruggedness test sample scope of accreditation solution solvent red 24 solvent yellow 124 specifications standard deviation Table tainty temperature test methods tion traceability trueness type of tests uncer uncertainty associated uncertainty estimation vali vendor verification Waldbronn