Validation Of Chromatography Data Systems

Author : Robert McDowall
Publisher : Royal Society of Chemistry
Page : 290 pages
File Size : 55,8 Mb
Release : 2007-10-31
Category : Science
ISBN : 9781847552297

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Validation of Chromatography Data Systems by Robert McDowall Pdf

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.

Author : Robert McDowall
Publisher : Royal Society of Chemistry
Page : 733 pages
File Size : 55,9 Mb
Release : 2016-11-23
Category : Science
ISBN : 9781782624073

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Validation of Chromatography Data Systems by Robert McDowall Pdf

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.

Author : Robert D. McDowall
Publisher : Unknown
Page : 289 pages
File Size : 40,8 Mb
Release : 2005
Category : Chromatographic analysis
ISBN : OCLC:176051053

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Validation of Chromatography Data Systems by Robert D. McDowall Pdf

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.

Author : Robert D. McDowall
Publisher : Royal Society of Chemistry
Page : 778 pages
File Size : 55,5 Mb
Release : 2016-11-25
Category : Science
ISBN : 9781849736626

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Validation of Chromatography Data Systems by Robert D. McDowall Pdf

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.

Author : Guy Wingate
Publisher : CRC Press
Page : 798 pages
File Size : 50,7 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420088953

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Pharmaceutical Computer Systems Validation by Guy Wingate Pdf

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 r

Author : David M. Bliesner
Publisher : John Wiley & Sons
Page : 301 pages
File Size : 40,8 Mb
Release : 2006-09-11
Category : Science
ISBN : 9780470042199

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Validating Chromatographic Methods by David M. Bliesner Pdf

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.

Author : Anonim
Publisher : Ispe Headquarters
Page : 128 pages
File Size : 48,7 Mb
Release : 2005-01-01
Category : Technology & Engineering
ISBN : 1931879397

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GAMP Good Practice Guide by Anonim Pdf

Author : Joachim Weiss
Publisher : John Wiley & Sons
Page : 1576 pages
File Size : 42,9 Mb
Release : 2016-06-24
Category : Science
ISBN : 9783527651641

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Handbook of Ion Chromatography by Joachim Weiss Pdf

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).

Author : R. D. McDowall
Publisher : Royal Society of Chemistry
Page : 660 pages
File Size : 53,5 Mb
Release : 2018-11-09
Category : Science
ISBN : 9781788012812

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Data Integrity and Data Governance by R. D. McDowall Pdf

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.

Author : Ludwig Huber
Publisher : CRC Press
Page : 268 pages
File Size : 40,5 Mb
Release : 2023-04-28
Category : Science
ISBN : 9781000948226

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Validation of Computerized Analytical Systems by Ludwig Huber Pdf

Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details. International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.

Author : Stavros Kromidas,Hans -Joachim Kuss
Publisher : John Wiley & Sons
Page : 377 pages
File Size : 44,5 Mb
Release : 2009-10-12
Category : Science
ISBN : 9783527323012

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Quantification in LC and GC by Stavros Kromidas,Hans -Joachim Kuss Pdf

Closing a gap in the current literature by addressing the evaluation and quality assessment of raw data, this practice-oriented guide is clearly divided into three parts. The first describes basic considerations of chromatographic data quality, common errors and potential pitfalls in reading out and quantifying the data. Part two systematically covers the most important chromatographic methods as well as the specific requirements for obtaining good chromatographic data. The final part looks at data quality from the perspective of those regulatory authorities demanding certain standards in data quality, describing in detail best practices. Written with the practitioner in mind, the text not only teaches the mathematical basics but also provides invaluable advice.

Author : Satinder Ahuja,Michael Dong
Publisher : Elsevier
Page : 600 pages
File Size : 48,9 Mb
Release : 2005-02-09
Category : Medical
ISBN : 0080455182

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Handbook of Pharmaceutical Analysis by HPLC by Satinder Ahuja,Michael Dong Pdf

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

Author : Michael E. Swartz,Ira S. Krull
Publisher : CRC Press
Page : 95 pages
File Size : 46,5 Mb
Release : 2018-10-03
Category : Science
ISBN : 9781482229776

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Analytical Method Development and Validation by Michael E. Swartz,Ira S. Krull Pdf

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 : Chung Chow Chan,Y. C. Lee,Herman Lam,Xue-Ming Zhang
Publisher : John Wiley & Sons
Page : 320 pages
File Size : 49,5 Mb
Release : 2004-04-23
Category : Science
ISBN : 9780471463719

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Analytical Method Validation and Instrument Performance Verification by Chung Chow Chan,Y. C. Lee,Herman Lam,Xue-Ming Zhang Pdf

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.

Author : Norman Dyson
Publisher : Royal Society of Chemistry
Page : 221 pages
File Size : 49,5 Mb
Release : 2007-10-31
Category : Science
ISBN : 9781847550514

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Chromatographic Integration Methods by Norman Dyson Pdf

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.