Download or read book Validation of Chromatography Data Systems written by R. D. McDowall and published by Royal Society of Chemistry. This book was released on 2005 with total page 306 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.

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.

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.

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.

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.

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.

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 679 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

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:

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 2018-11-06 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is the hottest topic in the pharmaceutical industry. Global regulatory agencies have issued guidance, after guidance after guidance in the past few years, most of which does not offer practical advice on how to implement policies, procedures and processes to ensure integrity. These guidances state what but not how. Additionally, key stages of analysis that impact data integrity are omitted entirely. The aim of this book is to provide practical and detailed help on how to implement data integrity and data governance for regulated analytical laboratories working in or for the pharmaceutical industry. It provides clarification of the regulatory issues and trends, and gives practical methods for meeting regulatory requirements and guidance. Using a data integrity model as a basis, the principles of data integrity and data governance are expanded into practical steps for regulated laboratories to implement. The author uses case study examples to illustrate his points and provides instructions for applying the principles of data integrity and data governance to individual laboratory needs. This book is a useful reference for analytical chemists and scientists, management and senior management working in regulated laboratories requiring either an understanding about data integrity or help in implementing practical solutions. Consultants will also benefit from the practical guidance provided.

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.

Download or read book Validation of Computerized Analytical Systems written by Ludwig Huber and published by CRC Press. This book was released on 2023-04-28 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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).

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.

Download or read book Managing the Analytical Laboratory written by Clifford Nilsen and published by CRC Press. This book was released on 1996-05-31 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear and concise manual on how to run a quality control testing laboratory efficiently and in compliance. Hundreds of tips and techniques help the reader focus on the essential elements of good laboratory management. This book includes thirty-nine useful SOPs that have evolved from the author's years of practical experience. Fifteen case studies describe typical laboratory problems and offer solutions to them. From how to train analysts, to how to lay out the laboratory, to how to assure that samples are processed in a systematic manner, Managing the Analytical Laboratory: Plain and Simple covers it all. Features

Download or read book Quantification in LC and GC written by Stavros Kromidas and published by John Wiley & Sons. This book was released on 2009-10-12 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Data Analysis and Signal Processing in Chromatography written by A. Felinger and published by Elsevier. This book was released on 1998-05-19 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives an overview of the numerical data analysis and signal treatment techniques that are used in chromatography and related separation techniques. Emphasis is given to the description of the symmetrical and asymmetrical chromatographic peak shape models. Both theoretical and empirical models are discussed.The fundamentals of data acquisition, types and effect of baseline noise, and methods of improving the signal-to-noise ratio (either in time or in frequency and wavelet domain) are thoroughly discussed. Resolution enhancement techniques, such as curve fitting, deconvolution by Fourier and wavelet transforms, iterative deconvolution, Kalman filtering and multivariate methods of curve resolution are all discussed with several chromatographic examples. Quantitative analysis by peak area of peak height measurement, the precision and accuracy of the quantitation of stand-alone or overlapping and symmetrical or asymmetrical peaks are treated. In a separate chapter, guidelines are given for the use of transform techniques for the analysis of chromatograms. A statistical description of peak overlap is given in the final chapters. Since the concept of resolution has to be reconsidered when one separates complex mixtures, the problem of resolution and overlap is quantitatively discussed by means of statistical methods, and by using Fourier analysis of the complex chromatogram.Features of this book• The ultimate source of numerical techniques to enhance chromatographic data• Gives a detailed description of signal and resolution enhancement techniques in a manner applicable for enhancing not only chromatography, but also spectroscopic and other analytical signals• The first book with a thorough overview of the statistics of peak overlap.This is the first volume to encompass both the simple and more sophisticated methods for the numerical treatment of chromatograms. It is, therefore, the fundamental resource of numerical analysis methods for every analyst.

Download or read book Handbook of LC MS Bioanalysis written by Wenkui Li and published by John Wiley & Sons. This book was released on 2013-10-21 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.