Valid Analytical Methods and Procedures

Valid Analytical Methods and Procedures
Author: Chris Burgess
Publisher: Royal Society of Chemistry
Total Pages: 98
Release: 2007-10-31
Genre: Science
ISBN: 1847552285

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
Author: Bernd W. Wenclawiak
Publisher: Springer Science & Business Media
Total Pages: 343
Release: 2010-08-05
Genre: Science
ISBN: 3642136095

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

Validation in Chemical Measurement

Validation in Chemical Measurement
Author: Paul De Bièvre
Publisher: Springer Science & Business Media
Total Pages: 190
Release: 2005-01-12
Genre: Science
ISBN: 9783540207887

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
Author: Joachim Ermer
Publisher: John Wiley & Sons
Total Pages: 418
Release: 2006-03-06
Genre: Science
ISBN: 3527604472

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
Author: D. Brynn Hibbert
Publisher: Oxford University Press
Total Pages: 306
Release: 2007-03-29
Genre: Science
ISBN: 9780195162134

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.

Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification
Author: Chung Chow Chan
Publisher: John Wiley & Sons
Total Pages: 320
Release: 2004-04-23
Genre: Science
ISBN: 047146371X

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.

Measurement Uncertainty in Chemical Analysis

Measurement Uncertainty in Chemical Analysis
Author: Paul De Bièvre
Publisher: Springer Science & Business Media
Total Pages: 294
Release: 2013-06-29
Genre: Science
ISBN: 3662051737

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.