PRACTICAL APPROACHES TO METHOD VALIDATION AND ESSENTIAL INSTRUMENT QUALIFICATION

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Practical Approaches To Method Validation And Essential Instrument Qualification

Author : Chung Chow Chan
ISBN : 9781118060315
Genre : Science
File Size : 61.24 MB
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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.
Category: Science

Handbook Of Lc Ms Bioanalysis

Author : Wenkui Li
ISBN : 9781118671351
Genre : Science
File Size : 70.55 MB
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Consolidates the information LC-MS bioanalytical scientistsneed to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by newapproaches for developing bioanalytical methods, new liquidchromatographic (LC) techniques, and new mass spectrometric (MS)instruments. Moreover, there are a host of guidelines andregulations designed to ensure the quality of bioanalyticalresults. Presenting the best practices, experimental protocols, and thelatest understanding of regulations, this book offers acomprehensive review of LC-MS bioanalysis of small molecules andmacromolecules. It not only addresses the needs of bioanalyticalscientists working on routine projects, but also explores advancedand emerging technologies such as high-resolution mass spectrometryand dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions froman international team of leading bioanalytical scientists. Theircontributions reflect a review of the latest findings, practices,and regulations as well as their own firsthand analyticallaboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drugdevelopment, and therapeutic drug monitoring The current understanding of regulations governing LC-MSbioanalysis Best practices and detailed technical instructions for LC-MSbioanalysis method development, validation, and stabilityassessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MSbioanalysis of challenging molecules, including pro-drugs, acylglucuronides, N-oxides, reactive compounds, and photosensitive andautooxidative compounds With its focus on current bioanalytical practice, Handbook ofLC-MS Bioanalysis enables bioanalytical scientists to developand validate robust LC-MS assay methods, all in compliance withcurrent regulations and standards.
Category: Science

Multivariate Analysis In The Pharmaceutical Industry

Author : Ana Patricia Ferreira
ISBN : 9780128110669
Genre : Medical
File Size : 54.60 MB
Format : PDF
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Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come
Category: Medical

Biophysics For Therapeutic Protein Development

Author : Linda O. Narhi
ISBN : 9781461443162
Genre : Medical
File Size : 46.52 MB
Format : PDF
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This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
Category: Medical

Particles And Nanoparticles In Pharmaceutical Products

Author : Henk G. Merkus
ISBN : 9783319941745
Genre : Technology & Engineering
File Size : 75.47 MB
Format : PDF, Mobi
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This edited volume brings together the expertise of numerous specialists on the topic of particles – their physical, chemical, pharmacological and toxicological characteristics – when they are a component of pharmaceutical products and formulations. The book discusses in detail properties such as the composition, size, shape, surface properties and porosity of particles with respect to how they impact the formulations and products in which they are used and the effective delivery of pharmaceutical active ingredients. It considers all dosage forms of pharmaceuticals involving particles, from powders to tablets, creams to ointments, and solutions to dry-powder inhalers, also including the latest nanomedicine products. Further, it discusses examples of particle toxicity, as well as the important subject of pharmaceutical industry regulations, guidelines and legislation. The book is of interest to researchers and practitioners who work on testing and developing pharmaceutical dosage and delivery systems.
Category: Technology & Engineering

Analytical Chemistry In A Gmp Environment

Author : James M. Miller
ISBN : 0471314315
Genre : Science
File Size : 83.2 MB
Format : PDF, Kindle
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How to hone your analytical skills and obtain high-quality data in the era of GMP requirements With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide. Based on Johnson & Johnson's acclaimed in-house training program, this practical guide provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies. Highly qualified industry experts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods-from spectroscopy to chromatography to dissolution. An ideal manual for formal training as well as an excellent self-study guide, Analytical Chemistry in a GMP Environment features: * The drug development process in the pharmaceutical industry * Uniform and consistent interpretation of GMP compliance issues * A review of the role of statistics and basic topics in analytical chemistry * An emphasis on high-performance liquid chromatographic (HPLC) methods * Chapters on detectors and quantitative analysis as well as data systems * Methods for ensuring that instruments meet standard operating procedures (SOP) requirements * Extensive appendixes for unifying terms, symbols, and procedural information
Category: Science

Validation In Chemical Measurement

Author : Paul De Bièvre
ISBN : 3540207880
Genre : Science
File Size : 86.79 MB
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The validation of analytical methods is based on the characterisation of a measurement procedure (selectivity, sensitivity, repeatability, reproducibility). This volume collects 31 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance". They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of validation into the standard procedures of every analytical laboratory. In addition, this anthology considers the benefits to both: the analytical laboratory and the user of the measurement results.
Category: Science

Seismic Engineering

Author : M. E. Nitzel
ISBN : 0791816214
Genre : Earthquake engineering
File Size : 20.75 MB
Format : PDF, ePub, Docs
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Category: Earthquake engineering