Valid Analytical Methods and Procedures PDF Download

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: 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: Mark Stauffer
Publisher: BoD – Books on Demand
ISBN: 1789230845
Category : Science
Languages : en
Pages : 176

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Book Description
This book seeks to introduce the reader to current methodologies in analytical calibration and validation. This collection of contributed research articles and reviews addresses current developments in the calibration of analytical methods and techniques and their subsequent validation. Section 1, "Introduction," contains the Introductory Chapter, a broad overview of analytical calibration and validation, and a brief synopsis of the following chapters. Section 2 "Calibration Approaches" presents five chapters covering calibration schemes for some modern analytical methods and techniques. The last chapter in this section provides a segue into Section 3, "Validation Approaches," which contains two chapters on validation procedures and parameters. This book is a valuable source of scientific information for anyone interested in analytical calibration and validation.

Author: Michael E. Swartz
Publisher: CRC Press
ISBN: 1482229773
Category : Science
Languages : en
Pages : 95

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Book Description
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

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

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Book Description

Author: James O. Westgard
Publisher: AACC Press
ISBN: 9781886958197
Category : Business & Economics
Languages : en
Pages : 292

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Book Description
With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.

Author: William P Gardiner
Publisher: Royal Society of Chemistry
ISBN: 1847551920
Category : Science
Languages : en
Pages : 390

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Book Description
Many forms of chemical experimentation generate data needing analysis and interpretation in respect of the goals of the experiment and also the chemical factors which may influence the outcome. Statistical data analysis techniques provide the tools which enable a chemist to assess the information obtained from experiments. Statistical Analysis Methods for Chemists: A Software-based Approach aims to give a broad introduction to practical data analysis, and provides comprehensive coverage of basic statistical principles and reasoning. With practical examples, and integration of software output as the basis of data analysis, this useful book gives unique coverage of the statistical skills and techniques required in modern chemical experimentation. It will prove invaluable to students and researchers alike. Software update information is available from W Gardiner at [email protected] or fax +44 (0)141 331 3608. Please accompany requests for information with details of the software version to be used.

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.

Author: Roger Wood
Publisher: Royal Society of Chemistry
ISBN: 1847551785
Category : Technology & Engineering
Languages : en
Pages : 326

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Book Description
Fit-for-purpose is a phrase familiar to all users of analytical data, who need to be assured that data provided by laboratories is both appropriate and of the required quality. Quality in the Food Analysis Laboratory surveys the procedures that a food analysis laboratory must consider to meet such requirements. The need to introduce quality assurance, the different quality models that are available and the legislative requirements are considered. Specific aspects of laboratory practice and particular areas of accreditation which may cause problems for analytical laboratories are also discussed. Covering for the first time those areas of direct importance to food analysis laboratories, this unique book will serve as an aid to those laboratories when introducing new measures and justifying those chosen.

Author: Florence Elizabeth Prichard
Publisher: Royal Society of Chemistry
ISBN: 9780854044436
Category : Education
Languages : en
Pages : 94

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Book Description
This unique handbook explains the most commonly used terminology and places each term in context. Concepts are described in a way that make them meaningful to practitioners and in line with ¿official definitions¿ developed by international organizations.