Juran On Quality By Design

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Juran On Quality By Design

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Author : Joseph M. Juran
language : en
Publisher:
Release Date : 1992

Juran On Quality By Design written by Joseph M. Juran and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Production management categories.

Pharmaceutical Quality By Design

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Author : Sarwar Beg
language : en
Publisher: Academic Press
Release Date : 2019-03-27

Pharmaceutical Quality By Design written by Sarwar Beg and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-27 with Medical categories.

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

Pharmaceutical Quality By Design

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Author : Walkiria S. Schlindwein
language : en
Publisher: John Wiley & Sons
Release Date : 2018-03-19

Pharmaceutical Quality By Design written by Walkiria S. Schlindwein and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-19 with Science categories.

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.

Introduction To Quality By Design In Pharmaceutical Manufacturing And Analytical Development

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Author : Márcia Cristina Breitkreitz
language : en
Publisher: Springer Nature
Release Date : 2023-07-13

Introduction To Quality By Design In Pharmaceutical Manufacturing And Analytical Development written by Márcia Cristina Breitkreitz and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-07-13 with Medical categories.

Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.

Pharmaceutical Quality By Design

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Author : Walkiria S. Schlindwein
language : en
Publisher: John Wiley & Sons
Release Date : 2018-01-05

Pharmaceutical Quality By Design written by Walkiria S. Schlindwein and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-05 with Science categories.

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.

Juran On Quality By Design

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Author : J. M. Juran
language : en
Publisher: Simon and Schuster
Release Date : 1992-05-04

Juran On Quality By Design written by J. M. Juran and has been published by Simon and Schuster this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992-05-04 with Business & Economics categories.

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.

Juran S Quality Handbook

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Author : J. M. Juran
language : en
Publisher: McGraw Hill Professional
Release Date : 1999-01-21

Juran S Quality Handbook written by J. M. Juran and has been published by McGraw Hill Professional this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-01-21 with Technology & Engineering categories.

For decades, Juran's Quality Handbook has been the one essential reference in quality management and engineering—the ultimate authoritative source of answers on quality applications, procedures, techniques, and strategies. Now this Fifth Edition—a major revision and the first new edition of Juran's Quality Handbook in more than 10 years—forges a new standard in tools for quality. Bringing managers and engineers the most up-to-date methods, research, and theory, under the guidance of a team of the world's top experts, Juran's shows you how to plan for quality, achieve quality control, and ensure quality results. Packed with new methods, research, and thought on quality, and emphasizing the need for quality software and quality software development methods, this completely updated classic also gives you new information, new techniques, and new applications. Broad in scope and inclusive in methodology, Juran's Quality Handbook is the reference of choice for anyone concerned with quality in business, manufacturing, or engineering. Whether you're just beginning your journey or a longtime traveler on the quality path, this book is the best possible companion for your voyage.

Juran S Quality Handbook The Complete Guide To Performance Excellence Seventh Edition

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Author : Joseph A. Defeo
language : en
Publisher: McGraw-Hill Education
Release Date : 2016-11-03

Juran S Quality Handbook The Complete Guide To Performance Excellence Seventh Edition written by Joseph A. Defeo and has been published by McGraw-Hill Education this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-03 with Technology & Engineering categories.

Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. The cornerstone text on quality management and performance excellence – thoroughly revised to reflect the latest challenges and developments The “body of knowledge” for the science of quality management and performance excellence for more than half-a-century, Juran’s Quality Handbook has been completely updated to meet the ever-changing needs of today’s business and quality professionals. Under the guidance of a team of top experts, this authoritative resource demonstrates how to apply the right methods for delivering superior results and achieving excellence in any organization, industry, or country. Juran’s Quality Handbook, Seventh Edition provides you with a complete roadmap for the discipline -- clearly written to make sure you know where you are in the process and what you must do to reach the next level. Within its pages, you will find A-Z coverage – from key concepts, methods, research, and tools to practical applications on the job. Here’s why this is the best edition yet: • Updated chapters on Lean, Six Sigma and the Shingo Prize • NEW chapters on Risk Management and Building a Quality Management System • NEW material on the history of quality management • All ISO and other regulatory standards have been updated • NEW statistical tables, charts, and data • Examples and case studies throughout demonstrate how others have applied the methods and tools discussed in real-world situations

Total Quality Management

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Author : D.R. Kiran
language : en
Publisher: Butterworth-Heinemann
Release Date : 2016-10-28

Total Quality Management written by D.R. Kiran and has been published by Butterworth-Heinemann this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-28 with Technology & Engineering categories.

Total Quality Management: Key Concepts and Case Studies provides the full range of management principles and practices that govern the quality function. The book covers the fundamentals and background needed, as well as industry case studies and comprehensive topic coverage, making it an invaluable reference to both the novice and the more experienced individual. Aspects of quality control that are widely utilized in practice are combined with those that are commonly referred to on University courses, and the latest developments in quality concepts are also presented. This book is an ideal quick reference for any manager, designer, engineer, or researcher interested in quality. - Features two chapters on the latest ISO standards - Includes an introduction to statistics to help the reader fully grasp content on statistical quality control - Contains case studies that explore many TQM themes in real life situations