Login

Gibson, Mark

Pharmaceutical Quality by Design: A Practical Approach

Gibson, Mark - Pharmaceutical Quality by Design: A Practical Approach, ebook

92,00€

Ebook, ePUB with Adobe DRM
ISBN: 9781118895214
DRM Restrictions

Printing110 pages with an additional page accrued every 7 hours, capped at 110 pages
Copy to clipboard5 excerpts

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.

Keywords: Chemical Engineering Fundamentals, Quality Assurance, Chemical Engineering Fundamentals, Quality Assurance,

Guide to Quality by Design for pharmaceutical industry; Guide to QbD for pharmaceutical industry; holistic approach to pharmaceutical manufacturing; QbD and FDA; QbD and manufacturing active pharmaceutical ingredients; principles of quality by design; principles of QbD; examples of QbD; QbD and risk management tools. Quality by Design and risk management analysis; quality by design and knowledge management; quality by design and manufacture of drug substance; quality by design and design of experiments; quality by design and the role of excipients; quality by design and multivariate analysis; Pharmaceutical Quality by Design A Practical Approach; Walkiria S. Schlindwein; Mark Gibson

Editor
 
Publisher
John Wiley and Sons, Inc.
Publication year
2015
Language
en
Edition
1
Series
Advances in Pharmaceutical Technology
Page amount
368 pages
Category
Technology, Energy, Traffic
Format
Ebook
eISBN (ePUB)
9781118895214
Printed ISBN
9781118895207

Similar titles