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 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 Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 368 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 in Design and Execution of Engineering Practice written by Lex A. Gunsteren and published by IOS Press. This book was released on 2013-05-29 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The quality your customers really need inevitably differs from the quality as prescribed in specifications, rules and regulations. The author's message is, in short, to be aware of this fact in all quality related issues. Quality as required by fitness for purpose can be in conflict with quality according to prevailing specifications, rules and regulations. It is then in the interest of the buyer to agree with the supplier on desirable exemptions. But often we can see that the supplier chooses the easy way out of just complying with the contract specifications without caring too much about the particular interests of the customer. In the Damen Shipyards Group, we try to induce a corporate culture of always paying attention to the interests of our customers and making serious efforts to serve those interests, also when there is no contractual obligation to do so. This book constitutes a welcome means to spread this word throughout the entire organisation. I wholeheartedly recommend it to whoever wishes to be a genuine quality supplier -- From publisher's provided.
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 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 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 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 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 Quality Engineering written by Chao-Ton Su and published by CRC Press. This book was released on 2016-04-19 with total page 394 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 Quality by Design for Electronics written by W. Fleischammer and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book concentrates on the quality of electronic products. Electronics in general, including semiconductor technology and software, has become the key technology for wide areas of industrial production. In nearly all expanding branches of industry electronics, especially digital electronics, is involved. And the spread of electronic technology has not yet come to an end. This rapid development, coupled with growing competition and the shorter innovation cycle, have caused economic problems which tend to have adverse effects on quality. Therefore, good quality at low cost is a very attractive goal in industry today. The demand for better quality continues along with a demand for more studies in quality assurance. At the same time, many companies are experiencing a drop in profits just when better quality of their products is essential in order to survive against the competition. There have been many proposals in the past to improve quality without increase in cost, or to reduce cost for quality assurance without loss of quality. This book tries to summarize the practical content of many of these proposals and to give some advice, above all to the designer and manufacturer of electronic devices. It mainly addresses practically minded engineers and managers. It is probably of less interest to pure scientists. The book covers all aspects of quality assurance of components used in electronic devices. Integrated circuits (lCs) are considered to be the most important components because the degree of integration is still rising.
Download or read book Design for Manufacturability Concurrent Engineering written by David M. Anderson and published by . This book was released on 2003 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Quality Assurance in Research and Development written by Roberts and published by CRC Press. This book was released on 1983-10-27 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chapter 7: PROJECT CONSTRUCTION -- I. MATERIAL IDENTIFICATION AND CONTROL -- II. CONTROL OF SPECIAL PROCESSES -- III. INSPECTION -- IV. HANDLING, STORAGE, AND SHIPPING -- V. NONCONFORMING MATERIALS, PARTS, OR COMPONENTS -- APPENDIX: AN ANALYSIS OF CORRECTIVE ACTION REPORTS GENERATED DURING A 3-YEAR PERIOD -- REFERENCES -- Chapter 8: CONTROL OFMEASURING AND TEST EQUIPMENT -- I. THE NEED FOR FORMAL CONTROL -- II. TRACEABILITY -- A. Definition of Traceability -- B. Purposes and Uses of Traceability -- C. Measurement Traceability and Standards Traceability -- D. The Question Posed to NBS -- E. NBS Advice on Traceability -- III. PROGRAM DESCRIPTION -- IV. SCOPE -- V. QUALITY LEVELS -- VI. CENTRALIZED CONTROL -- VII. CALIBRATION PROCEDURES -- IX. EVALUATION OF CALIBRATION SUPPLIERS -- REFERENCES -- Chapter 9: TEST CONTROL -- I. TEST PLAN -- II. TEST PROCEDURES -- III . DOCUMENTATION AND REVIEW OF RESULTS -- REFERENCES -- Chapter 10: SOFTWARE -- I. BACKGROUND -- II. THE SOFTWARE QUALITY ASSURANCE PROGRAM -- A. Planning -- B. Software Quality Levels and QA Plans -- C. Software Development Process -- D. Evaluation -- REFERENCES -- Chapter 11: RECORDS AND REPORTING -- I. PROJECT RECORDS -- II. REPORTS -- III. TRACEABILITY -- IV. RETENTION -- REFERENCES -- Chapter 12: AUDITING THE PROGRAM -- I. GENERAL AUDITING CONSIDERATIONS -- II. PROJECTS -- A. Specified QA -- B. Standard Laboratory Practice -- III. SYSTEM AUDITS -- IV. SUPPLIER AUDITS -- REFERENCES -- INDEX
Download or read book Cell Culture Engineering written by Gyun Min Lee and published by John Wiley & Sons. This book was released on 2020-01-13 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offers a comprehensive overview of cell culture engineering, providing insight into cell engineering, systems biology approaches and processing technology In Cell Culture Engineering: Recombinant Protein Production, editors Gyun Min Lee and Helene Faustrup Kildegaard assemble top class authors to present expert coverage of topics such as: cell line development for therapeutic protein production; development of a transient gene expression upstream platform; and CHO synthetic biology. They provide readers with everything they need to know about enhancing product and bioprocess attributes using genome-scale models of CHO metabolism; omics data and mammalian systems biotechnology; perfusion culture; and much more. This all-new, up-to-date reference covers all of the important aspects of cell culture engineering, including cell engineering, system biology approaches, and processing technology. It describes the challenges in cell line development and cell engineering, e.g. via gene editing tools like CRISPR/Cas9 and with the aim to engineer glycosylation patterns. Furthermore, it gives an overview about synthetic biology approaches applied to cell culture engineering and elaborates the use of CHO cells as common cell line for protein production. In addition, the book discusses the most important aspects of production processes, including cell culture media, batch, fed-batch, and perfusion processes as well as process analytical technology, quality by design, and scale down models. -Covers key elements of cell culture engineering applied to the production of recombinant proteins for therapeutic use -Focuses on mammalian and animal cells to help highlight synthetic and systems biology approaches to cell culture engineering, exemplified by the widely used CHO cell line -Part of the renowned "Advanced Biotechnology" book series Cell Culture Engineering: Recombinant Protein Production will appeal to biotechnologists, bioengineers, life scientists, chemical engineers, and PhD students in the life sciences.
