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Author : Ispe
Publisher :
ISBN 13 : 9781931879453
Total Pages : pages
Book Rating : 4.51/5 ( download)
Download or read book ISPE Baseline® Guide: Volume 5 - Commissioning and Qualification written by Ispe and published by . This book was released on 2006-05 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781931879064
Total Pages : 0 pages
Book Rating : 4.60/5 ( download)
Download or read book ISPE Baseline® Guide written by Ispe and published by . This book was released on 2001-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : International Society for Pharmaceutical Engineering
Publisher :
ISBN 13 : 9781936379088
Total Pages : 116 pages
Book Rating : 4.82/5 ( download)
Download or read book ISPE Guide written by International Society for Pharmaceutical Engineering and published by . This book was released on 2011 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : James Agalloco
Publisher : CRC Press
ISBN 13 : 1000436012
Total Pages : 1062 pages
Book Rating : 4.13/5 ( download)
Download or read book Handbook of Validation in Pharmaceutical Processes, Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
Author : Ispe
Publisher :
ISBN 13 : 9781931879729
Total Pages : pages
Book Rating : 4.29/5 ( download)
Download or read book ISPE Baseline® Guide written by Ispe and published by . This book was released on 2010-01-25 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Walkiria S. Schlindwein
Publisher : John Wiley & Sons
ISBN 13 : 1118895215
Total Pages : 319 pages
Book Rating : 4.14/5 ( download)
Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Chung Chow Chan
Publisher : John Wiley & Sons
ISBN 13 : 047146371X
Total Pages : 320 pages
Book Rating : 4.19/5 ( download)
Download or read book Analytical Method Validation and Instrument Performance Verification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2004-04-23 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
Author : David Roesti
Publisher : John Wiley & Sons
ISBN 13 : 1119356075
Total Pages : 594 pages
Book Rating : 4.73/5 ( download)
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Guy Wingate
Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 773 pages
Book Rating : 4.53/5 ( download)
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
Author : ISPE
Publisher :
ISBN 13 : 9781931879255
Total Pages : 19 pages
Book Rating : 4.57/5 ( download)
Download or read book GAMP Good Practice Guide written by ISPE and published by . This book was released on 2002 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt:
