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How To Integrate Quality By Efficient Design Qbed In Product Development

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How to Integrate Quality by Efficient Design QbED in Product Development

How to Integrate Quality by Efficient Design  QbED  in Product Development Book
Author : Bhavishya Mittal
Publisher : Academic Press
Release : 2019-08-24
ISBN : 0128173041
Language : En, Es, Fr & De

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Book Description :

The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development Discusses relevant literature references in quality risk management, business strategy, QbD, and product development Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand

Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design Book
Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
Publisher : Academic Press
Release : 2021-01-09
ISBN : 0128203331
Language : En, Es, Fr & De

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Book Description :

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

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation Book
Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Release : 2019-04-15
ISBN : 0128094125
Language : En, Es, Fr & De

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Book Description :

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Design for Six Sigma

Design for Six Sigma Book
Author : Elizabeth A. Cudney,Tina Kanti Agustiady
Publisher : CRC Press
Release : 2016-08-05
ISBN : 1498742564
Language : En, Es, Fr & De

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Book Description :

Design for Six Sigma (DFSS) is an innovative continuous improvement methodology for designing new products, processes, and services by integrating Lean and Six Sigma principles. This book will explain how the DFSS methodology is used to design robust products, processes, or services right the first time by using the voice of the customer to meet Six Sigma performance. Robust designs are insensitive to variation and provide consistent performance in the hands of the customer. DFSS is used to meet customer needs by understanding their requirements, considering current process capability, identifying and reducing gaps, and verifying predictions to develop a robust design. This book offers: Methodology on how to implement DFSS in various industries Practical examples of the use of DFSS Sustainability utilizing Lean Six Sigma techniques and Lean product development Innovative designs using DFSS with concept generation Case studies for implementing the DFSS methodology Design for Six Sigma (DFSS) enables organizations to develop innovative designs. In order to redesign an existing process or design a new process, the success is dependent on a rigorous process and methodology. DFSS ensures that there are minimal defects in the introduction of new products, processes, or services. The authors have compiled all of the tools necessary for implementation of a practical approach though innovation.

Revolutionizing Product Development

Revolutionizing Product Development Book
Author : Steven C. Wheelwright,Kim B. Clark
Publisher : Simon and Schuster
Release : 1992-06-15
ISBN : 0029055156
Language : En, Es, Fr & De

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Book Description :

Today, a company's capability to conceive and design quality prototypes and bring a variety of superior products to market quicker than its competitors is increasingly the focal point of competition, contend leading product development experts Steven Wheelwright and Kim Clark. Drawing on six years of in-depth, systematic, worldwide research, they present proven principles for developing the critical capabilities for speed, efficiency, and quality that have worked again and again in scores of successful Japanese, American, and European fast-cycle firms. The authors argue that to survive, let alone succeed, today's companies must construct a new "platform" -- with new methodologies -- on which they can compete. Using their model for development strategies, Wheelwright and Clark show that firms can create a solid architecture for the integration of marketing, manufacturing, and design functions for problem solving and fast action -- particularly during the critical design-build-test cycles of prototype creation. They demonstrate further how successful firms such as Honda in automobiles, Compaq in personal computers, Applied Materials in semi-conductors, Sony in audio equipment, The Limited in apparel, and Hill-Rom in hospital beds have employed recent methodologies to bring new products to market at break-neck speed. Such innovations include design for manufacturability, quality function deployment, computer-aided design, and computer-aided engineering. Finally, Wheelwright and Clark emphasize the importance of learning in the organization. Companies that consistently "design it right the first time" and follow a path of continuous improvement in product and process development have a formidable edge in the crucial race to market.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Book
Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publisher : John Wiley & Sons
Release : 2017-08-30
ISBN : 1119356164
Language : En, Es, Fr & De

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Book Description :

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.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Book
Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publisher : John Wiley & Sons
Release : 2017-09-01
ISBN : 1119356172
Language : En, Es, Fr & De

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Book Description :

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.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publisher : Academic Press
Release : 2016-11-08
ISBN : 0128026375
Language : En, Es, Fr & De

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Book Description :

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Miscellaneous Publication

Miscellaneous Publication Book
Author : Anonim
Publisher : Unknown
Release : 1981
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Miscellaneous Publication book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Integrated Pharmaceutics

Integrated Pharmaceutics Book
Author : Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner
Publisher : John Wiley & Sons
Release : 2022-09-07
ISBN : 1119574188
Language : En, Es, Fr & De

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Book Description :

This work is an examination of all aspects of the science in developing effective dosage form for drug delivery Pharmaceutics refers to the subfield of pharmaceutical sciences that develops drug delivery products or devices to optimize the drug's performance once administered. This multidisciplinary field draws on physical chemistry, organic chemistry, and biophysics to generate and refine these crucial elements of medical care. Moreover, incorporating such disparate dimensions of drug product design as material properties and legal regulation bridges the gap between effective chemicals and viable medical treatments. Integrated Pharmaceutics provides a comprehensive introduction to the creation and manufacture of effective dosage forms for drug delivery. It presents its subject following the principles of physical pharmacy, product design, and drug regulations. This tripartite structure allows readers to move from theory to practice, beginning from a firm foundation of physical pharmacy principles, including drug solubility and stability estimation, rheology, and interfacial properties. From there, it proceeds to discussions of drug product design and of harmonizing pharmaceutical design with the regulatory regimens and technological standards of the United States, European Union, and Japan. Readers of the second edition of Integrated Pharmaceutics will also find: A glossary defining key terms, extensive informative appendices, and a list of references leading to the primary literature in the field for each chapter Earlier chapters are expanded, with additional new chapters including one entitled “Biotechnology Products” Supplementary instructor guide with questions and solutions available online for registered professors Updated regulatory guidelines including quality by design, design space analysis, process analytical technology, polymorphism characterization, blend sample uniformity, and stability protocols Integrated Pharmaceutics is a useful textbook for graduate students in pharmaceutical sciences, drug formulation and design, and biomedical engineering. In addition, professionals in the pharmaceutical industry, including regulatory bodies, will find it a helpful reference guide.

Formulation and Analytical Development for Low Dose Oral Drug Products

Formulation and Analytical Development for Low Dose Oral Drug Products Book
Author : Jack Zheng
Publisher : John Wiley & Sons
Release : 2009-02-09
ISBN : 0470056096
Language : En, Es, Fr & De

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Book Description :

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Computer aided applications in pharmaceutical technology

Computer aided applications in pharmaceutical technology Book
Author : Jelena Djuris,Svetlana Ibric,Zorica Djuric
Publisher : Elsevier Inc. Chapters
Release : 2013-04-10
ISBN : 0128091878
Language : En, Es, Fr & De

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Book Description :

This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept is presented from both regulatory and manufacturers’ points of view. Several illustrative examples are provided to facilitate the understanding of the QbD concept and ease of its application.

Design of Experiments for Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development Book
Author : Sarwar Beg
Publisher : Springer Nature
Release : 2021-01-12
ISBN : 9813347171
Language : En, Es, Fr & De

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Book Description :

This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.

Design of Experiments for Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development Book
Author : Sarwar Beg
Publisher : Springer Nature
Release : 2021-01-22
ISBN : 9813343516
Language : En, Es, Fr & De

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Book Description :

This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.

Improvement of Buildings Structural Quality by New Technologies

Improvement of Buildings  Structural Quality by New Technologies Book
Author : Christian Schauer,ENG. Federico Mazzolani,Gerald Huber,Gianfranco de Matteis,Heiko Trumpf,Heli Koukkari,Jean-Pierre Jaspart,Luis Bragança
Publisher : CRC Press
Release : 2005-01-20
ISBN : 9780415366090
Language : En, Es, Fr & De

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Book Description :

Launched in May 2000, the aims of the COST C12 cooperative action were: to develop, combine and disseminate new technical engineering technologies to improve the quality of urban buildings to propose new technical solutions to architects and planners to reduce the disturbance caused by construction in urban areas and improve urban quality of life. This volume contains the proceedings of the COST C12 final conference held in Innsbruck, Austria from January 20-22 2005. The book reflects not only the outcome of the four years’ work of the cooperative, but also the contributions made by other international experts at the conference, focused on three broad themes: mixed building technology; structural integrity under exceptional actions; and urban design.

Setting the PACE in Product Development

Setting the PACE in Product Development Book
Author : Michael E. McGrath
Publisher : Routledge
Release : 1996
ISBN : 075069789X
Language : En, Es, Fr & De

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Book Description :

Setting the PACE in Product Development describes how to effectively manage the key ingredients of successful product development: time, quality, talent and resources. This revised edition of Product Development provides essential insight as to how to efficiently organize people, resources and processes to dramatically improve financial results, strategic positions, internal morale and customer satisfaction. The PACE techniques integrate vital company-wide functions, engaging the entire company and focusing its collective energy on strategically and financially important goals. Previously in hardback, now in paperback with 3 new chapters on product strategy, technology management and cross-project management. Popular proven method of success for achieving efficiency in product development and cycle time. A must for anyone who needs quality results in a timely fashion.

Textile Technology Digest

Textile Technology Digest Book
Author : Anonim
Publisher : Unknown
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Textile Technology Digest book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Chemical Product Design

Chemical Product Design Book
Author : E. L. Cussler,Edward Lansing Cussler,G. D. Moggridge,G. D.. Moggridge
Publisher : Cambridge University Press
Release : 2001-04-16
ISBN : 9780521791830
Language : En, Es, Fr & De

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Book Description :

Ground-breaking text on chemical product design covering needs, ideas, selection, manufacture.

NASA Tech Briefs

NASA Tech Briefs Book
Author : Anonim
Publisher : Unknown
Release : 2006
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download NASA Tech Briefs book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Quality Strategy for Research and Development

Quality Strategy for Research and Development Book
Author : Ming-Li Shiu,Jui-Chin Jiang,Mao-Hsiung Tu
Publisher : John Wiley & Sons
Release : 2013-06-19
ISBN : 1118672666
Language : En, Es, Fr & De

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Book Description :

Provides a clear, useful framework and methods for R&D,including robust technology development, product planning, andproduct design and development management Quality Strategy for Research and Development integratesthe Japanese and Western perspectives on Quality FunctionDeployment (QFD), updates the strategy of Robust Engineering (RE),and relates their unique frameworks to current, widely adoptedphilosophies of quality assurance. Featuring real-world case studies, more than thirty tables, andover seventy figures, this essential guide identifies key issuesand proposes improvements in the current R&D paradigm. Itoffers in-depth coverage of technology development, productplanning, and product design and development management. Quality Strategy for Research and Development: Updates the conventional approaches to QFD and RE, and providesthe implementation model of combining them into a corporateoperating system Identifies key issues in the current practice of R&D, andprovides solutions for improving design quality and R&Dproductivity Includes the case studies of designing a functional circuit,magnetic component, measurement system, and machiningequipment Offers the integration models of QFD and other breakthroughstrategies including DFX (Design For eXcellence), DFSS (Design ForSix Sigma), and Blue Ocean Strategy Written for R&D executives, managers, engineers, and qualitypractitioners, Quality Strategy for Research and Developmentis also an ideal text for professors and students of industrial andsystems engineering, technology management, and businessadministration.