Quality Through Design

Author : Walkiria S. Schlindwein,Mark Gibson
Publisher : John Wiley & Sons
Page : 368 pages
File Size : 53,7 Mb
Release : 2018-01-05
Category : Science
ISBN : 9781118895214

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Pharmaceutical Quality by Design by Walkiria S. Schlindwein,Mark Gibson Pdf

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.

Author : Sarwar Beg,Md Saquib Hasnain
Publisher : Academic Press
Page : 448 pages
File Size : 50,7 Mb
Release : 2019-03-27
Category : Business & Economics
ISBN : 9780128163726

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Pharmaceutical Quality by Design by Sarwar Beg,Md Saquib Hasnain Pdf

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

Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publisher : John Wiley & Sons
Page : 418 pages
File Size : 41,8 Mb
Release : 2017-10-09
Category : Science
ISBN : 9780470942376

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Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz Pdf

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.

Author : N. Logothetis,Henry P. Wynn
Publisher : Oxford University Press, USA
Page : 486 pages
File Size : 45,8 Mb
Release : 1994
Category : Business & Economics
ISBN : UOM:35128001963741

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Quality Through Design by N. Logothetis,Henry P. Wynn Pdf

The main purpose of this book is to encourage the proper implementation of the techniques which have contributed to Japan's industrial success. Designing for quality is the next evolutionary stage in quality systems, a stage that industries need to embrace.

Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H Almalki
Publisher : Academic Press
Page : 225 pages
File Size : 48,6 Mb
Release : 2021-01-09
Category : Business & Economics
ISBN : 9780128203330

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Handbook of Analytical Quality by Design by Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H Almalki Pdf

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

Author : G. Ross Baker
Publisher : Longwoods Publishing
Page : 291 pages
File Size : 42,6 Mb
Release : 2008
Category : Health facilities
ISBN : 0981008909

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High Performing Healthcare Systems by G. Ross Baker Pdf

Author : John Fox
Publisher : McGraw-Hill Companies
Page : 248 pages
File Size : 51,5 Mb
Release : 1993
Category : Business & Economics
ISBN : STANFORD:36105009769899

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Quality Through Design by John Fox Pdf

Focuses on the concept of managing the critical functional parameters of a design and explains how these functional aspects can be evaluated prior to testing. It shows how, through monitoring the quality of a product throughout its life-cycle, the sequence of "design-build-test" could be reduced.

Author : J. M. Juran
Publisher : Simon and Schuster
Page : 552 pages
File Size : 46,9 Mb
Release : 1992-05-04
Category : Business & Economics
ISBN : 9780029166833

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Juran on Quality by Design by J. M. Juran Pdf

J.M. Juran, whom Business Week calls, "the man who taught Japan how to manage for quality", presents a new, exhaustively comprehensive approach to planning, setting, and reaching goals in Juran's Quality Road Map. New emphasis is placed on setting goals, planning in "multifunctional" processes, establishing data bases, motivating managers and introducing quality planning into organizations. 30 line drawings.

Author : Anonim
Publisher : Unknown
Page : 56 pages
File Size : 42,5 Mb
Release : 2001
Category : Estuarine area conservation
ISBN : UCR:31210024815191

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The Soundfront Series: Protecting estuarine water quality through design by Anonim Pdf

Author : Thomas B. Barker,Andrew Milivojevich
Publisher : CRC Press
Page : 740 pages
File Size : 42,8 Mb
Release : 2016-01-27
Category : Business & Economics
ISBN : 9781482249675

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Quality by Experimental Design by Thomas B. Barker,Andrew Milivojevich Pdf

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

Author : Rob Lievense
Publisher : Unknown
Page : 436 pages
File Size : 40,8 Mb
Release : 2018-10
Category : Computers
ISBN : 1629608645

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Pharmaceutical Quality by Design Using JMP by Rob Lievense Pdf

Solve your pharmaceutical product development and manufacturing problems using JMP®. Pharmaceutical Quality by Design Using JMP®: Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of Quality by Design (QbD), there is a growing emphasis to optimize the processing of products. This book uses practical examples from the pharmaceutical and medical device industries to illustrate easy-to-understand ways of incorporating QbD elements using JMP. Pharmaceutical Quality by Design Using JMP® opens by demonstrating the easy navigation of JMP to visualize data through the distribution function and the graph builder and then highlights the following: the powerful dynamic nature of data visualization that enables users to be able to quickly extract meaningful information tools and techniques designed for the use of structured, multivariate sets of experiments examples of complex analysis unique to healthcare products such as particle size distributions/drug dissolution, stability of drug products over time, and blend uniformity/content uniformity. Scientists, engineers, and technicians involved throughout the pharmaceutical and medical device product life cycles will find this book invaluable. This book is part of the SAS Press program.

Author : Khosrow Dehnad
Publisher : Springer Science & Business Media
Page : 287 pages
File Size : 54,8 Mb
Release : 2012-12-06
Category : Technology & Engineering
ISBN : 9781468414721

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Quality Control, Robust Design, and the Taguchi Method by Khosrow Dehnad Pdf

In 1980, I received a grant from Aoyama-gakuin university to come to the United States to assist American Industry improve the quality of their products. In a small way this was to repay the help the US had given Japan after the war. In the summer of 1980, I visited the AT&T Bell Laboratories Quality Assurance Center, the organization that founded modern quality control. The result of my first summer at AT&T was an experiment with an orthogonal array design of size 18 (OA18) for optimization of an LSI fabrication process. As a measure of quality, the quantity "signal-ta-noise" ratio was to be optimized. Since then, this experi mental approach has been named "robust design" and has attracted the attention of both engineers and statisticians. My colleagues at Bell Laboratories have written several expository articles and a few theoretical papers on robust design from the viewpoint of statistics. Because so many people have asked for copies of these papers, it has been decided to publish them in a book form. This anthology is the result of these efforts. Despite the fact that quality engineering borrows some technical words from traditional design of experiments, the goals of quality engineering are different from those of statistics. For example, suppose there are two vendors. One vendor supplies products whose quality characteristic has a normal distribution with the mean on target (the desired value) and a certain standard deviation.

Author : Eugene C. Nelson,Paul B. Batalden,Marjorie M. Godfrey
Publisher : John Wiley & Sons
Page : 507 pages
File Size : 53,6 Mb
Release : 2011-01-14
Category : Medical
ISBN : 9781118046838

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Quality By Design by Eugene C. Nelson,Paul B. Batalden,Marjorie M. Godfrey Pdf

Quality by Design reflects the research and applied training conducted at Dartmouth Medical School under the leadership of Gene Nelson, Paul Batalden, and Marjorie Godfrey. The book includes the research results of high-performing clinical microsystems, illustrative case studies that highlight individual clinical programs, guiding principles that are easily applied, and tools, techniques, and methods that can be adapted by clinical practices and interdisciplinary clinical teams. The authors describe how to develop microsystems that can attain peak performance through active engagement of interdisciplinary teams in learning and applying improvement science and measurement; explore the essence of leadership for clinical Microsystems; show what mid-level leaders can do to enable peak performance at the front lines of care; outline the design and redesign of services and planning care to match patient needs with services offered; examine the issue of safety; describe the vital role of data in creating a rich and useful information environment; provide a core curriculum that can build microsystems’ capability, provide excellent care, promote a positive work environment, and contribute to the larger organization. Ancillary materials for use in classroom teaching, training, or coaching are available at https://clinicalmicrosystem.org/

Author : Balbir S. Dhillon
Publisher : CRC Press
Page : 316 pages
File Size : 41,7 Mb
Release : 1985-03-19
Category : Technology & Engineering
ISBN : 0824772784

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Quality Control, Reliability, and Engineering Design by Balbir S. Dhillon Pdf

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.

Author : N. K. Jain
Publisher : Springer Nature
Page : 505 pages
File Size : 42,9 Mb
Release : 2024-06-28
Category : Electronic
ISBN : 9789819980345

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Introduction to Quality by Design (QbD) by N. K. Jain Pdf