Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices
Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Author: Rosamund M. Baird

Publisher: CRC Press

Published: 2000-08-17

Total Pages: 274

ISBN-13: 0203305191

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Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi

Pharmaceutical Manufacturing Handbook
Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2008-04-04

Total Pages: 857

ISBN-13: 0470259825

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With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.

Pharmaceutical Quality by Design
Pharmaceutical Quality by Design

Author: Walkiria S. Schlindwein

Publisher: John Wiley & Sons

Published: 2018-01-05

Total Pages: 319

ISBN-13: 1118895215

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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.

Pharmaceutical Quality by Design
Pharmaceutical Quality by Design

Author: Sarwar Beg

Publisher: Academic Press

Published: 2019-03-27

Total Pages: 450

ISBN-13: 0128163720

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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 Microbiological Quality Assurance and Control
Pharmaceutical Microbiological Quality Assurance and Control

Author: David Roesti

Publisher: John Wiley & Sons

Published: 2020-01-02

Total Pages: 594

ISBN-13: 1119356075

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Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

Juran's Quality Handbook: The Complete Guide to Performance Excellence, Seventh Edition
Juran's Quality Handbook: The Complete Guide to Performance Excellence, Seventh Edition

Author: Joseph A. Defeo

Publisher: McGraw-Hill Education

Published: 2016-11-03

Total Pages: 0

ISBN-13: 9781259643613

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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

Pharmaceutical Quality Systems
Pharmaceutical Quality Systems

Author: Oliver Schmidt

Publisher: CRC Press

Published: 2000-04-30

Total Pages: 393

ISBN-13: 142002602X

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When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr