Download or read book Engineering Quality by Design written by Thomas B. Barker and published by CRC Press. This book was released on 1990-08-31 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Engineering Quality by Design written by Thomas B. Barker and published by CRC Press. This book was released on 1990-08-31 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.
Download or read book Quality by Design written by Nicolo Belavendram and published by . This book was released on 1995 with total page 616 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the intention of making Taguchi techniques more widely understood, this book covers product and process experiments designed to help quality-manufacturing-design engineers make these products and processes more robust.
Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Download or read book Quality by Design for Biopharmaceuticals written by Anurag S. Rathore and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Download or read book Engineering Quality and Experimental Design written by Daniel Michael Grove and published by Longman Scientific and Technical. This book was released on 1992 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Keeping formulae to a minimum, the authors explain the fundamental ideas involved in planning efficient experiments and making good use of the results. Their strategies are inspired by the Japanese engineer Genichi Taguchi, but they show how many of Taguchi's objectives can be accomplished using simpler methods and modern computer technology. Annotation copyright by Book News, Inc., Portland, OR
Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-08 with total page 1435 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies
Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende and published by John Wiley & Sons. This book was released on 2019-04-23 with total page 1172 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying Presents updated and expanded example calculations Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industryf ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.
Download or read book Handbook of Analytical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2021-01-09 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance
Download or read book Robust Design for Quality Engineering and Six Sigma written by Sung H. Park and published by World Scientific. This book was released on 2008 with total page 558 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is written primarily for engineers and researchers who use statistical robust design for quality engineering and Six Sigma, and for statisticians who wish to know about the wide range of applications of experimental design in industry. It is a valuable guide and reference material for students, managers, quality improvement specialists and other professionals interested in Taguchi's robust design methods as well as the implementation of Six Sigma. This book can also be useful to those who would like to learn about the role of Robust Design within the Six Sigma (Improve phase) methodology and Design for Six Sigma (DFSS) (Optimize) methodology. It combines classical experimental design methods with those of Taguchi's robust designs, demonstrating their prowess in DFSS and suggesting new directions for the development of statistical design and analysis.
Download or read book Quality Engineering Using Robust Design written by Madhav Phadke and published by . This book was released on 2021-07-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The book presents a systematic and efficient method to design high quality / reliability and high performance products / processes at low cost. Contains case studies from diverse engineering fields to describe Robust Design / Taguchi method.Some topics covered are: orthogonal arrays, Signal-to-Noise ratios as design quality metric, computer-aided robust design techniques, and more.
Download or read book Quality by Experimental Design written by Thomas B. Barker and published by CRC Press. This book was released on 2016-01-27 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Achieve Technological Advancements in Applied Science and Engineering Using Efficient Experiments That Consume the Least Amount of ResourcesWritten by longtime experimental design guru Thomas B. Barker and experimental development/Six Sigma expert Andrew Milivojevich, Quality by Experimental Design, Fourth Edition shows how to design and analyze ex
Download or read book Quality Control Reliability and Engineering Design written by Balbir S. Dhillon and published by CRC Press. This book was released on 1985-03-19 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the first time in a single volume, quality control, reliability, and design engineers have a comprehensive overview of how each of their disciplines interact to achieve optimum product and/or project success. Thoroughly covering every stage of each phase, this outstanding reference provides detailed discussions of techniques and methods, ensuring cost-effective and time-saving procedures ... contains over 80 solved problems -- as well as numerous end-of-chapter exercises -- for reinforcement of essential material ... presents a complete, relevant mathematics chapter that eliminates the need to refer to other math texts ... offers self-contained chapters with introductions, summaries, and extensive references for quick, easy reading and additional study. Quality Control, Reliability, and Engineering Design is a key, on-the-job source for quality control, reliability, and design engineers and managers; system engineers and managers; and mechanical, electrical and electronic, industrial, and project engineers and managers. The book also serves as an ideal reference for professional seminars and in-house training programs, as well as for upper-level undergraduate and graduate courses in Quality Control, Reliability, Quality Control and Reliability, and Quality Control of Engineering Design. Book jacket.
Download or read book Quality Engineering written by Chao-Ton Su and published by CRC Press. This book was released on 2016-04-19 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: As quality becomes an increasingly essential factor for achieving business success, building quality improvement into all stages—product planning, product design, and process design—instead of just manufacturing has also become essential. Quality Engineering: Off-Line Methods and Applications explores how to use quality engineering methods and other modern techniques to ensure design optimization at every stage. The book takes a broad approach, focusing on the user’s perspective and building a well-structured framework for the study and implementation of quality engineering. Starting with the basics, this book presents an overall picture of quality engineering. The author delineates quality engineering methods such as DOE, Taguchi, and RSM as well as computational intelligence approaches. He discusses how to use a general computational intelligence approach to improve product quality and process performance. He also provides extensive examples and case studies, numerous exercises, and a glossary of basic terms. By adopting quality engineering, the defect rate during manufacturing shows noticeable improvement, the production cost is significantly lower, and the quality and reliability of products can be enhanced. Taking an integrated approach that makes the methods of upstream quality improvement accessible, without extensive mathematical treatments, this book is both a practical reference and an excellent textbook.
Download or read book Engineering Methods for Robust Product Design written by William Y. Fowlkes and published by Prentice Hall. This book was released on 1995 with total page 403 pages. Available in PDF, EPUB and Kindle. Book excerpt: Robust Design is the procedure used by design engineers to reduce the effects of order to produce the highest quality products possible. This book includes real life case studies focusing on mechanical, chemical and imaging design that illustrate potential problems and their solutions and offers WinRobust Lite software and practice problems.
