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: 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: Bernd W. Wenclawiak
Publisher: Springer Science & Business Media
ISBN: 3642136095
Category : Science
Languages : en
Pages : 343

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knowledge. This material provided has been collected from different sources. One important source is the material available from EURACHEM. Eurachem is a network of organisations in Europe having the objective of establishing a system for the international tra- ability of chemical measurements and the promotion of good quality practices. It provides a forum for the discussion of common problems and for developing an informed and considered approach to both technical and policy issues. It provides a focus for analytical chemistry and quality related issues in Europe. You can find more information about EURACHEM on the internet via “Eurachem –A Focus for Analytical Chemistry in Europe” (http://www.eurachem.org). In particular the site Guides and Documents contains a number of different guides, which might help you to set up a quality system in your laboratory. The importance of quality assurance in analytical chemistry can best be described by the triangles depicted in Figs. 1 and 2. Quality is checked by testing and testing guaranties good quality. Both contribute to progress in QA (product control and quality) and thus to establishing a market share. Market success depends on quality, price, and flexibility. All three of them are interconnected. Before you can analyse anything the sample must be taken by someone. This must be of major concern to any analytical chemist. There is no accurate analysis wi- out proper sampling. For correct sampling you need a clear problem definition. There is no correct sampling without a clear problem definition

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: 9783540207887
Category : Science
Languages : en
Pages : 190

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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.

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

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

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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: A Fajgelj
Publisher: Royal Society of Chemistry
ISBN: 1847551750
Category : Science
Languages : en
Pages : 317

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Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a large number of samples are to be analysed. Much of the content relates to the validation of new methods for pesticide residue analysis in foodstuffs and water but the principles can be applied to other similar fields of analysis. Different chromatographic methods are discussed, including estimation of various effects, eg. matrix-induced effects and the influence of the equipment set-up. The methods used for routine purposes and the validation of analytical data in the research and development environment are documented. The legislation covering the EU-Guidance on residue analytical methods, an extensive review of the existing in-house method validation documentation and guidelines for single-laboratory validation of analytical methods for trace-level concentrations of organic chemicals are also included. With contributions from experts in the field, any practising analyst dealing with method validation will find the examples presented in this book a useful source of technical information.

Author: Uwe Zerbst
Publisher: Academic Press
ISBN: 0080552838
Category : Technology & Engineering
Languages : en
Pages : 313

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The purpose of Fitness-for-Service Fracture Assessment of Structures Containing Cracks is to facilitate the use of fracture mechanics based failure assessment procedures for the evaluation and design of structures and components. All practical structures contain flaws and the optimum combination of cost efficiency and safety whilst achieving the required capability, can only be realised by using state of the art methods such as that represented by the European flaw assessment method SINTAP/FITNET to analyse the safety risk. This book is written by practitioners with extensive experience in both the development and use of integrity assessment methods and provides comprehensive information on the basic principles and use of analytical flaw assessment. It provides an introduction to the method, its background, how it can be applied, its potential and, importantly, its limitations. The explanations are complimented by using a large number of worked examples and validation exercises which illustrate all aspects of the procedure. In addition, for students and engineers who are new to the subject, a comprehensive glossary of basic terms used in fracture mechanics based integrity evaluations is included. The topics addressed include: - Crack driving force (CDF) and failure assessment diagram (FAD) type analyses - Preparation of the input parameters (crack dimensions, stress-strain properties, fracture toughness, statistical aspects) - Determination of the model parameters, (stress intensity factor and yield load solutions) - Treatment of combined primary and secondary loading, together with residual stress effects - Analysis of the effect of constraint effects (treatment of small defects and section size effects) - Treatment of mixed mode loading - Consideration of the influences of strength mismatch - Reliability aspects - Comprehensive description of the use of structural integrity methods to optimise cost effectiveness and safety - Detailed description of how to evaluate the integrity of structures containing cracks - Valuable background information for understanding the methods, their potential and limitations - Large number of worked examples, which demonstrate all aspects of the methods - Descriptive, readable writing style - Applicable to a wide range of interests, from the student (university or self study) to the expert who requires a 'state of the art' document