The Fitness for Purpose of Analytical Methods PDF Download

Author:
Publisher:
ISBN: 9780948926129
Category : Chemistry, Analytic
Languages : en
Pages : 54

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Author:
Publisher:
ISBN: 9789187461590
Category : Chemistry, Analytic
Languages : en
Pages : 70

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Book Description

Author: Chris Burgess
Publisher: Royal Society of Chemistry
ISBN: 1847552285
Category : Science
Languages : en
Pages : 98

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Book Description
The Analytical Methods Committee of the Royal Society of Chemistry has for many years been involved in national and international efforts to establish a comprehensive framework for achieving appropriate quality in chemical measurement. This handbook attempts to select or define robust procedures that ensure the best use of resources and enable laboratories to generate consistent, reliable data. Written in concise, easy-to-read language and illustrated with worked examples, it is a guide to current best practice and establishes a control framework for the development and validation of laboratory-based analytical methods. Topics include samples and sampling, method selection, equipment calibration and qualification, method development and validation, evaluation of data and statistical approaches for method performance and comparison. Valid Analytical Methods and Procedures will be welcomed by many organisations throughout the world who are required to prove that the validity of their analytical results can be established beyond reasonable doubt.

Author: Christopher Burgess
Publisher: Royal Society of Chemistry
ISBN: 9780854044825
Category : Education
Languages : en
Pages : 102

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Book Description
This handbook defines procedures that ensure the best use of resources and enables laboratories to generate consistent, reliable data. Written in a concise, easy-to-read language and illustrated with worked examples, this is a guide to the best practices and methods. A control framework for the development and validation of laboratory-based analytical methods is established. Particular attention is given to the sample, methods chosen, instrumentation, personnel, and calculations used.

Author: Bernd W. Wenclawiak
Publisher: Springer
ISBN: 3662096218
Category : Science
Languages : en
Pages : 306

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Book Description
Quality Assurance in Chemical Measurement, an advanced EURACHEM textbook, provides in-depth but easy-to-understand coverage for training, teaching and continuing studies. The CD-ROM accompanying the book contains course materials produced by ten experienced specialists, including more than 750 overheads (graphics and text) in ready-to-use PowerPoint® documents in English and German language. The book will serve as an advanced textbook for analytical chemistry students and professionals in industry and service labs and as a reference text and source of course materials for lecturers. The second edition has been completely revised according to the newest legislation.

Author: Eurachem/CITAC Working Group
Publisher:
ISBN: 9780948926150
Category : Chemistry, Analytic
Languages : en
Pages : 120

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Author: Paul De Bièvre
Publisher: Springer Science & Business Media
ISBN: 3662051737
Category : Science
Languages : en
Pages : 294

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Book Description
It is now becoming recognized in the measurement community that it is as important to communicate the uncertainty related to a specific measurement as it is to report the measurement itself. Without knowing the uncertainty, it is impossible for the users of the result to know what confidence can be placed in it; it is also impossible to assess the comparability of different measurements of the same parameter. This volume collects 20 outstanding papers on the topic, mostly published from 1999-2002 in the journal "Accreditation and Quality Assurance." They provide the rationale for why it is important to evaluate and report the uncertainty of a result in a consistent manner. They also describe the concept of uncertainty, the methodology for evaluating uncertainty, and the advantages of using suitable reference materials. Finally, the benefits to both the analytical laboratory and the user of the results are considered.

Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418

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Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

Author: D. Brynn Hibbert
Publisher: Oxford University Press
ISBN: 9780195162134
Category : Science
Languages : en
Pages : 306

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Book Description
Analytical chemical results touch everyone's lives: Can we eat the food? Do I have a disease? Did the defendant leave his DNA at the crime scene? Should I invest in that gold mine? When a chemist measures something, how do we know that the result is appropriate? What is "fit for purpose" in the context of analytical chemistry? Quality Assurance for the Analytical Chemistry Laboratory explains the practices that chemistry laboratories adopt so that we all can have confidence in the answers to these questions.

Author: Paul De Bièvre
Publisher: Springer Science & Business Media
ISBN: 9783540207887
Category : Science
Languages : en
Pages : 190

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Book Description
The validation of analytical methods is based on the characterisation of a measurement procedure (selectivity, sensitivity, repeatability, reproducibility). This volume collects 31 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance". They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of validation into the standard procedures of every analytical laboratory. In addition, this anthology considers the benefits to both: the analytical laboratory and the user of the measurement results.