The Fitness for Purpose of Analytical Methods

The Fitness for Purpose of Analytical Methods PDF Author:
Publisher:
ISBN: 9780948926129
Category : Chemistry, Analytic
Languages : en
Pages : 54

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Book Description

The Fitness for Purpose of Analytical Methods

The Fitness for Purpose of Analytical Methods PDF Author:
Publisher:
ISBN: 9780948926129
Category : Chemistry, Analytic
Languages : en
Pages : 54

Get Book Here

Book Description


Valid Analytical Methods and Procedures

Valid Analytical Methods and Procedures PDF 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.

Quality Assurance in Analytical Chemistry

Quality Assurance in Analytical Chemistry PDF 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.

Quantifying Uncertainty in Analytical Measurement

Quantifying Uncertainty in Analytical Measurement PDF Author: Eurachem/CITAC Working Group
Publisher:
ISBN: 9780948926150
Category : Chemistry, Analytic
Languages : en
Pages : 120

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Book Description


Validation in Chemical Measurement

Validation in Chemical Measurement PDF 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.

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis PDF Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418

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Book Description
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.

Quality Assurance in the Analytical Chemistry Laboratory

Quality Assurance in the Analytical Chemistry Laboratory PDF 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.

Principles and Practices of Method Validation

Principles and Practices of Method Validation PDF Author: A Fajgelj
Publisher: Royal Society of Chemistry
ISBN: 1847551750
Category : Science
Languages : en
Pages : 317

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Book Description
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.

Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification PDF Author: Chung Chow Chan
Publisher: John Wiley & Sons
ISBN: 047146371X
Category : Science
Languages : en
Pages : 320

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Book Description
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.

Animal Feed Contamination

Animal Feed Contamination PDF Author: J Fink-Gremmels
Publisher: Elsevier
ISBN: 0857093614
Category : Technology & Engineering
Languages : en
Pages : 705

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Book Description
The production of animal feed increasingly relies on the global acquisition of feed material, increasing the risk of chemical and microbiological contaminants being transferred into food-producing animals. Animal feed contamination provides a comprehensive overview of recent research into animal feed contaminants and their negative effects on both animal and human health.Part one focuses on the contamination of feeds and fodder by microorganisms and animal by-products. Analysis of contamination by persistent organic pollutants and toxic metals follows in part two, before the problem of natural toxins is considered in part three. Veterinary medicinal products as contaminants are explored in part four, along with a discussion of the use of antimicrobials in animal feed. Part five goes on to highlight the risk from emerging technologies. Finally, part six explores feed safety and quality management by considering the safe supply and management of animal feed, the process of sampling for contaminant analysis, and the GMP+ feed safety assurance scheme.With its distinguished editor and international team of expert contributors, Animal feed contamination is an indispensable reference work for all those responsible for food safety control in the food and feed industries, as well as a key source for researchers in this area. - Provides a comprehensive review of research into animal feed contaminants and their negative effects on both animal and human health - Examines the contamination of feeds and fodder by microorganisms and animal by-products - Analyses contamination by persistant organic pollutants, toxic metals and natural toxins