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 Analytical Method Validation and Instrument Performance Verification written by Chung Chow Chan and published by Wiley-Interscience. This book was released on 2004-01-28 with total page 303 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 Practical Approaches to Method Validation and Essential Instrument Qualification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2011-03-01 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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.

Download or read book Guidance for the Validation of Analytical Methodology and Calibration of Equipment Used for Testing of Illicit Drugs in Seized Materials and Biological Specimens written by United Nations and published by United Nations Publications. This book was released on 2009 with total page 67 pages. Available in PDF, EPUB and Kindle. Book excerpt: The validation of analytical methods and the calibration of equipment are important aspects of quality assurance in the laboratory. This manual deals with both of these within the context of testing of illicit drugs in seized materials and biological specimens. It provides an introduction and practical guidance to national authorities and analysts in the implementation of method validation and verification, and also in the calibration/performance verification of laboratory instrumentation and equipment within their existing internal quality assurance programmes. The procedures described represent a synthesis of the experience of scientists from several reputable laboratories around the world.

Download or read book Calibration and Validation of Analytical Methods written by Mark Stauffer and published by BoD – Books on Demand. This book was released on 2018-04-25 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Analytical Instrumentation written by Graham Currell and published by John Wiley & Sons. This book was released on 2008-04-30 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2014-11-10 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Analytical Method Development and Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2018-10-03 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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.

Download or read book Validation and Qualification in Analytical Laboratories Second Edition written by Ludwig Huber and published by CRC Press. This book was released on 2007-07-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Fitness for Purpose of Analytical Methods written by and published by . This book was released on 1998-01-01 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices GIVIMP written by OECD and published by OECD Publishing. This book was released on 2018-12-10 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...

Download or read book Challenges in Analytical Quality Assurance written by Manfred Reichenbächer and published by Springer Science & Business Media. This book was released on 2011-02-16 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: Working in the lab, but unsure what your results actually mean? Would you like to know how to apply trueness tests, calculate standard deviations, estimate measurement uncertainties or test for linearity? This book offers you a problem-based approach to analytical quality assurance (AQA). After a short introduction into required fundamentals, various topics such as statistical tests, linear regression and calibration, tool qualification or method validation are presented in the form of exercises for self-study. Solutions are provided in a clear step-by-step manner. Interactive Excel-sheets are available as Extra Materials for trying out the various concepts. For professionals as well as graduate students confronted with analytical quality assurance for the first time, this book will be the clue to meeting such challenges.

Download or read book Guideline for Submitting Samples and Analytical Data for Methods Validation written by and published by . This book was released on 1987 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Chromatographic Analysis of Pharmaceuticals written by John A. Adamovics and published by Routledge. This book was released on 2017-09-29 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated and revised throughout. Second Edition explores the chromatographic methods used for the measurement of drugs, impurities, and excipients in pharmaceutical preparations--such as tablets, ointments, and injectables. Contains a 148-page table listing the chromatographic data of over 1300 drugs and related substances--including sample matrix analyzed, sample handling procedures, column packings, mobile phase, mode of detection, and more.