analytical method validation and instrument performance verification

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Analytical Method Validation And Instrument Performance Verification

Author : Chung Chow Chan
ISBN : 047146371X
Genre : Science
File Size : 32. 39 MB
Format : PDF
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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.

Analytical Method Validation And Instrument Performance Verification

Author : Chung Chow Chan
ISBN : 0471259535
Genre : Medical
File Size : 47. 40 MB
Format : PDF, Mobi
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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.

Practical Approaches To Method Validation And Essential Instrument Qualification

Author : Chung Chow Chan
ISBN : 9781118060315
Genre : Science
File Size : 37. 27 MB
Format : PDF, ePub
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Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.

Method Validation In Pharmaceutical Analysis

Author : Joachim Ermer
ISBN : 9783527672189
Genre : Medical
File Size : 72. 25 MB
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This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

Validation And Qualification In Analytical Laboratories Second Edition

Author : Ludwig Huber
ISBN : 084938267X
Genre : Medical
File Size : 55. 24 MB
Format : PDF
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This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

Biotransformations In Organic Chemistry

Author : Kurt Faber
ISBN : 9783319615905
Genre : Science
File Size : 64. 64 MB
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This well-established textbook on biocatalysis provides a basis for undergraduate and graduate courses in modern organic chemistry, as well as a condensed introduction into this field. After a basic introduction into the use of biocatalysts—principles of stereoselective transformations, enzyme properties and kinetics—the different types of reactions are explained according to the 'reaction principle', such as hydrolysis, reduction, oxidation, C–C bond formation, etc. Special techniques, such as the use of enzymes in organic solvents, immobilization techniques, artificial enzymes and the design of cascade-reactions are treated in a separate section. A final chapter deals with the basic rules for the safe and practical handling of biocatalysts. The use of biocatalysts, employed either as isolated enzymes or whole microbial cells, offers a remarkable arsenal of highly selective transformations for state-of-the-art synthetic organic chemistry. Over the last two decades, this methodology has become an indispensable tool for asymmetric synthesis, not only at the academic level, but also on an industrial scale. In this 7th edition new topics have been introduced which include alcohol and amine oxidases, amine dehydrogenases, imine reductases, haloalkane dehalogenases, ATP-independent phosphorylation, Michael-additions and cascade reactions. This new edition also emphasizes the use of enzymes in industrial biotransformations with practical examples.

Laboratory Instrumentation

Author : Mary C. Haven
ISBN : 0471285722
Genre : Medical
File Size : 50. 29 MB
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An exhuastive guide to modern medical diagnostic and testing equipment, this completely updated book features coverage of every major type of instrumentation found in the clinical lab, vital information on more than 50 instrument manufacturers, plus high-quality illustrations that clearly display instrument components. 190 illustrations.

Analytical Instrumentation

Author : Dr. Graham Currell
ISBN : 9780470511299
Genre : Science
File Size : 55. 55 MB
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There is an increasing need for analysts to understand and be able to quantify the performance of analytical instruments, in particular with respect to the following: * specifying equipment for purchase * estimating uncertainties in instrumental measurements * quantifying and demonstrating performance quality This text links together an understanding of performance characteristics with an appreciation of the limitations imposed by instrument design, leading to the interplay of the validation and qualification processes within quality assurance systems. A unique framework of topics covers the major instrumental techniques of spectrophotometry, chromatography, capillary electrophoresis, and atomic emission spectroscopy. The use of over 200 questions and answers, together with cross-referencing, helps to develop a thorough understanding of the various concepts that underpin the different techniques. This book will appeal to a broad range of professional chemists, technicians and students, whether with reference to specific analytical techniques, or within a general course of study in instrumental performance. Analytical Techniques in the Sciences This series of books provides coverage of all the major analytical techniques and their application in the most important areas of physical, life and materials sciences. Each text is presented in an open learning/distant learning style, in which the learning objectives are clearly identified. The reader's understanding of the material is constantly evaluated by the use of self-assessment and discussion questions.

Microanalysis Of Solids

Author : B.G. Yacobi
ISBN : 030644433X
Genre : Science
File Size : 66. 36 MB
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This book systematically describes the most widely used techniques for the microanalysis of the physical, structural, and compositional properties of solids. Covering electron beams, ion beams, photon beams, and acoustic waves, it will provide physicists, materials scientists, electrical engineers, chemists, and their students with a comprehensive reference source.

The Fitness For Purpose Of Analytical Methods

Author :
ISBN : 0948926120
Genre : Chemistry, Analytic
File Size : 86. 82 MB
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