Validation Of Chromatography Data Systems

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Validation of Chromatography Data Systems

Author : Robert McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 1847552293
Total Pages : 290 pages
Book Rating : 4.8/5 (475 download)

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Book Synopsis Validation of Chromatography Data Systems by : Robert McDowall

Download or read book Validation of Chromatography Data Systems written by Robert McDowall and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures. This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.

Validation of Chromatography Data Systems

Author : Robert McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 1782624074
Total Pages : 733 pages
Book Rating : 4.7/5 (826 download)

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Book Synopsis Validation of Chromatography Data Systems by : Robert McDowall

Download or read book Validation of Chromatography Data Systems written by Robert McDowall and published by Royal Society of Chemistry. This book was released on 2016-11-23 with total page 733 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.

Validation of Chromatography Data Systems

Author : Robert D. McDowall
Publisher :
ISBN 13 :
Total Pages : 289 pages
Book Rating : 4.:/5 (176 download)

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Book Synopsis Validation of Chromatography Data Systems by : Robert D. McDowall

Download or read book Validation of Chromatography Data Systems written by Robert D. McDowall and published by . This book was released on 2005 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the.

Validation of Chromatography Data Systems

Author : Robert D. McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 1849736626
Total Pages : 778 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Validation of Chromatography Data Systems by : Robert D. McDowall

Download or read book Validation of Chromatography Data Systems written by Robert D. McDowall and published by Royal Society of Chemistry. This book was released on 2016-11-25 with total page 778 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.

Validating Chromatographic Methods

Author : David M. Bliesner
Publisher : John Wiley & Sons
ISBN 13 : 0470042192
Total Pages : 301 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Validating Chromatographic Methods by : David M. Bliesner

Download or read book Validating Chromatographic Methods written by David M. Bliesner and published by John Wiley & Sons. This book was released on 2006-09-11 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a supplementary support site, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.

Analytical Method Validation and Instrument Performance Verification

Author : Chung Chow Chan
Publisher : John Wiley & Sons
ISBN 13 : 047146371X
Total Pages : 320 pages
Book Rating : 4.4/5 (714 download)

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Book Synopsis Analytical Method Validation and Instrument Performance Verification by : Chung Chow Chan

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.

GAMP Good Practice Guide

Author :
Publisher : Ispe Headquarters
ISBN 13 : 9781931879392
Total Pages : pages
Book Rating : 4.8/5 (793 download)

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Book Synopsis GAMP Good Practice Guide by :

Download or read book GAMP Good Practice Guide written by and published by Ispe Headquarters. This book was released on 2005-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Computer Systems Validation

Author : Guy Wingate
Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 773 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Pharmaceutical Computer Systems Validation by : Guy Wingate

Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Data Integrity and Data Governance

Author : R. D. McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 178801281X
Total Pages : 660 pages
Book Rating : 4.7/5 (88 download)

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Book Synopsis Data Integrity and Data Governance by : R. D. McDowall

Download or read book Data Integrity and Data Governance written by R. D. McDowall and published by Royal Society of Chemistry. This book was released on 2018-11-09 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.

Chromatographic Integration Methods

Author : Norman Dyson
Publisher : Royal Society of Chemistry
ISBN 13 : 1847550517
Total Pages : 221 pages
Book Rating : 4.8/5 (475 download)

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Book Synopsis Chromatographic Integration Methods by : Norman Dyson

Download or read book Chromatographic Integration Methods written by Norman Dyson and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of the popular Chromatographic Integration Methods has been completely revised and updated. Written by an expert with many years' experience with two of the world's largest manufacturers of computing integrators, it has been expanded to include a new section on validation of integrators in response to regulatory requirements for quality and validation. A new literature survey, additional diagrams and Author Index have also been added. Well illustrated and easily read, this is an excellent source book for those who wish to increase their understanding of integrators. Chromatographic Integration Methods describes and discusses both manual and electronic techniques used, with the aim of aiding analysts to obtain more data from their chromatograms, and assist them with understanding how integrators work so that results are never accepted unquestioningly. As with the first edition, this book will be welcomed by all those in the chromatography field, particularly those at the bench.

Method Validation in Pharmaceutical Analysis

Author : Joachim Ermer
Publisher : John Wiley & Sons
ISBN 13 : 3527604472
Total Pages : 418 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Method Validation in Pharmaceutical Analysis by : Joachim Ermer

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.

Handbook of Pharmaceutical Analysis by HPLC

Author : Satinder Ahuja
Publisher : Elsevier
ISBN 13 : 9780080455181
Total Pages : 600 pages
Book Rating : 4.4/5 (551 download)

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Book Synopsis Handbook of Pharmaceutical Analysis by HPLC by : Satinder Ahuja

Download or read book Handbook of Pharmaceutical Analysis by HPLC written by Satinder Ahuja and published by Elsevier. This book was released on 2005-02-09 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling

Chemometrics in Chromatography

Author : Łukasz Komsta
Publisher : CRC Press
ISBN 13 : 1498772544
Total Pages : 506 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Chemometrics in Chromatography by : Łukasz Komsta

Download or read book Chemometrics in Chromatography written by Łukasz Komsta and published by CRC Press. This book was released on 2018-02-02 with total page 506 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chemometrics uses advanced mathematical and statistical algorithms to provide maximum chemical information by analyzing chemical data, and obtain knowledge of chemical systems. Chemometrics significantly extends the possibilities of chromatography and with the technological advances of the personal computer and continuous development of open-source software, many laboratories are interested in incorporating chemometrics into their chromatographic methods. This book is an up-to-date reference that presents the most important information about each area of chemometrics used in chromatography, demonstrating its effective use when applied to a chromatographic separation.

HPLC and UHPLC for Practicing Scientists

Author : Michael W. Dong
Publisher : John Wiley & Sons
ISBN 13 : 1119313767
Total Pages : 410 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis HPLC and UHPLC for Practicing Scientists by : Michael W. Dong

Download or read book HPLC and UHPLC for Practicing Scientists written by Michael W. Dong and published by John Wiley & Sons. This book was released on 2019-07-23 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise yet comprehensive reference guide on HPLC/UHPLC that focuses on its fundamentals, latest developments, and best practices in the pharmaceutical and biotechnology industries Written for practitioners by an expert practitioner, this new edition of HPLC and UHPLC for Practicing Scientists adds numerous updates to its coverage of high-performance liquid chromatography, including comprehensive information on UHPLC (ultra-high-pressure liquid chromatography) and the continuing migration of HPLC to UHPLC, the modern standard platform. In addition to introducing readers to HPLC’s fundamentals, applications, and developments, the book describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. HPLC and UHPLC for Practicing Scientists, Second Edition offers three new chapters. One is a standalone chapter on UHPLC, covering concepts, benefits, practices, and potential issues. Another examines liquid chromatography/mass spectrometry (LC/MS). The third reviews at the analysis of recombinant biologics, particularly monoclonal antibodies (mAbs), used as therapeutics. While all chapters are revised in the new edition, five chapters are essentially rewritten (HPLC columns, instrumentation, pharmaceutical analysis, method development, and regulatory aspects). The book also includes problem and answer sections at the end of each chapter. Overviews fundamentals of HPLC to UHPLC, including theories, columns, and instruments with an abundance of tables, figures, and key references Features brand new chapters on UHPLC, LC/MS, and analysis of recombinant biologics Presents updated information on the best practices in method development, validation, operation, troubleshooting, and maintaining regulatory compliance for both HPLC and UHPLC Contains major revisions to all chapters of the first edition and substantial rewrites of chapters on HPLC columns, instrumentation, pharmaceutical analysis, method development, and regulatory aspects Includes end-of-chapter quizzes as assessment and learning aids Offers a reference guide to graduate students and practicing scientists in pharmaceutical, biotechnology, and other industries Filled with intuitive explanations, case studies, and clear figures, HPLC and UHPLC for Practicing Scientists, Second Edition is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology. It will be a great benefit to every busy laboratory analyst and researcher.

Chromatographic Integration Methods

Author : Norman Allen Dyson
Publisher :
ISBN 13 :
Total Pages : 184 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Chromatographic Integration Methods by : Norman Allen Dyson

Download or read book Chromatographic Integration Methods written by Norman Allen Dyson and published by . This book was released on 1990 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is one in a series designed for the individual chromatographer, providing guidance and advice on a wide range of chromatographic techniques with emphasis on important practical aspects of the subject.

Principles and Practices of Method Validation

Author : A Fajgelj
Publisher : Royal Society of Chemistry
ISBN 13 : 1847551750
Total Pages : 317 pages
Book Rating : 4.8/5 (475 download)

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Book Synopsis Principles and Practices of Method Validation by : A Fajgelj

Download or read book Principles and Practices of Method Validation written by A Fajgelj and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Handbook of Ion Chromatography

Author : Joachim Weiss
Publisher : John Wiley & Sons
ISBN 13 : 3527651640
Total Pages : 1576 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Handbook of Ion Chromatography by : Joachim Weiss

Download or read book Handbook of Ion Chromatography written by Joachim Weiss and published by John Wiley & Sons. This book was released on 2016-06-24 with total page 1576 pages. Available in PDF, EPUB and Kindle. Book excerpt: This three-volume handbook is the standard reference in the field, unparalleled in its comprehensiveness. It covers every conceivable topic related to the expanding and increasingly important field of ion chromatography. The fourth edition is completely updated and revised to include the latest developments in the instrumentation, now stretching to three volumes to reflect the current state of applications. Ion chromatography is one of the most widely used separation techniques of analytical chemistry with applications in fields such as medicinal chemistry, water chemistry and materials science. Consequently, the number of users of this method is continuously growing, underlining the need for an up-to-date reference. A true pioneer of this method, Joachim Weiss studied chemistry at the Technical University of Berlin (Germany), where he also received his PhD degree in Analytical Chemistry. In 2002, he did his habilitation in Analytical Chemistry at the Leopold-Franzens University in Innsbruck (Austria), where he is also teaching liquid chromatography. Since 1982, Dr. Weiss has worked at Dionex (now being part of Thermo Fisher Scientific), where he currently holds the position of Technical Director for Dionex Products within the Chromatography and Mass Spectrometry Division (CMD) of Thermo Fisher Scientific, located in Dreieich (Germany).