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Download or read book The Fitness for Purpose of Analytical Methods written by and published by . This book was released on 1998-01-01 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Fitness for Purpose of Analytical Methods written by and published by . This book was released on 2014 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author: Christopher Burgess
Publisher: Royal Society of Chemistry
Published: 2000
Total Pages: 102
ISBN-13: 9780854044825
DOWNLOAD EBOOKThis 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.
Download or read book Valid Analytical Methods and Procedures written by Christopher Burgess and published by Royal Society of Chemistry. This book was released on 2000 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Published: 2013-12-20
Total Pages: 306
ISBN-13: 3662096218
DOWNLOAD EBOOKQuality 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.
Download or read book Quality Assurance in Analytical Chemistry written by Bernd W. Wenclawiak and published by Springer. This book was released on 2013-12-20 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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:
Published: 2000-01-01
Total Pages: 120
ISBN-13: 9780948926150
DOWNLOAD EBOOKDownload or read book Quantifying Uncertainty in Analytical Measurement written by Eurachem/CITAC Working Group and published by . This book was released on 2000-01-01 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author: Paul De Bièvre
Publisher: Springer Science & Business Media
Published: 2013-06-29
Total Pages: 294
ISBN-13: 3662051737
DOWNLOAD EBOOKIt 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.
Download or read book Measurement Uncertainty in Chemical Analysis written by Paul De Bièvre and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Published: 2006-03-06
Total Pages: 418
ISBN-13: 3527604472
DOWNLOAD EBOOKAdopting 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.
Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Published: 2005-01-12
Total Pages: 190
ISBN-13: 9783540207887
DOWNLOAD EBOOKThe 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.
Download or read book Validation in Chemical Measurement written by Paul De Bièvre and published by Springer Science & Business Media. This book was released on 2005-01-12 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Published: 2007-03-29
Total Pages: 306
ISBN-13: 9780195162134
DOWNLOAD EBOOKAnalytical 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.
Download or read book Quality Assurance in the Analytical Chemistry Laboratory written by D. Brynn Hibbert and published by Oxford University Press. This book was released on 2007-03-29 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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: Chung Chow Chan
Publisher: John Wiley & Sons
Published: 2004-04-23
Total Pages: 320
ISBN-13: 047146371X
DOWNLOAD EBOOKValidation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
Download or read book Analytical Method Validation and Instrument Performance Verification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2004-04-23 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
