The Pharmaceutical Quality Control Handbook
Author : Rhys Bryant
Publisher :
Page : 232 pages
File Size : 19,94 MB
Release : 1984
Category : Medical
ISBN :
Author : Rhys Bryant
Publisher :
Page : 232 pages
File Size : 19,94 MB
Release : 1984
Category : Medical
ISBN :
Author : Rosamund M. Baird
Publisher : CRC Press
Page : 274 pages
File Size : 36,96 MB
Release : 2000-08-17
Category : Medical
ISBN : 0203305191
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
Author : Murray Sam Cooper
Publisher :
Page : 312 pages
File Size : 25,71 MB
Release : 1972
Category : Law
ISBN :
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 857 pages
File Size : 10,74 MB
Release : 2008-04-04
Category : Science
ISBN : 0470259825
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.
Author : Mr. Manohar A. Potdar
Publisher : Pragati Books Pvt. Ltd.
Page : 424 pages
File Size : 37,66 MB
Release : 2006
Category : Pharmaceutical industry
ISBN : 9788185790596
Author : Sarwar Beg
Publisher : Academic Press
Page : 450 pages
File Size : 24,60 MB
Release : 2019-03-27
Category : Medical
ISBN : 0128163720
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 : David Roesti
Publisher : John Wiley & Sons
Page : 594 pages
File Size : 30,20 MB
Release : 2020-01-02
Category : Technology & Engineering
ISBN : 1119356075
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
Author : Oliver Schmidt
Publisher : CRC Press
Page : 392 pages
File Size : 18,50 MB
Release : 2000-04-30
Category : Medical
ISBN : 142002602X
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
Author : Walkiria S. Schlindwein
Publisher : John Wiley & Sons
Page : 319 pages
File Size : 41,92 MB
Release : 2018-01-05
Category : Science
ISBN : 1118895215
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 : Eugenia Gabriela Carrillo-Cedillo
Publisher :
Page : pages
File Size : 11,63 MB
Release : 2022
Category : Drugs
ISBN : 9781799896142
"This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients"--