Pharmaceutical Process Validation
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How To Validate A Pharmaceutical Process
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Author : Steven Ostrove
language : en
Publisher: Academic Press
Release Date : 2016-06-07
How To Validate A Pharmaceutical Process written by Steven Ostrove and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-06-07 with Medical categories.
How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more
Validation Of Pharmaceutical Processes
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Author : James P. Agalloco
language : en
Publisher: CRC Press
Release Date : 2007-09-25
Validation Of Pharmaceutical Processes written by James P. Agalloco and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-09-25 with Medical categories.
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Pharmaceutical Process Validation
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Author : Bernard T. Loftus
language : en
Publisher: Marcel Dekker
Release Date : 1984
Pharmaceutical Process Validation written by Bernard T. Loftus and has been published by Marcel Dekker this book supported file pdf, txt, epub, kindle and other format this book has been release on 1984 with Business & Economics categories.
Pharmaceutical Process Validation Second Edition
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Author : Ira R. Berry
language : en
Publisher: CRC Press
Release Date : 1993-01-29
Pharmaceutical Process Validation Second Edition written by Ira R. Berry and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993-01-29 with Science categories.
Updated to reflect current good manufacturing practice (CGMP) regulations, this text discusses current concepts in validation. New topics covered include: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.
Pharmaceutical Process Validation
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Author : Robert A. Nash
language : en
Publisher: CRC Press
Release Date : 2003-03-27
Pharmaceutical Process Validation written by Robert A. Nash and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-03-27 with Medical categories.
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Pharmaceutical Process Validation
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Author : Robert A. Nash
language : en
Publisher: CRC Press
Release Date : 2003-03-27
Pharmaceutical Process Validation written by Robert A. Nash and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-03-27 with Medical categories.
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Solid Oral Dose Process Validation Volume Two
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Author : Ajay Pazhayattil
language : en
Publisher: Springer Nature
Release Date : 2019-08-30
Solid Oral Dose Process Validation Volume Two written by Ajay Pazhayattil and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-30 with Medical categories.
The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.
Pharmaceutical Process Validation
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Author : Robert A. Nash
language : en
Publisher: CRC Press
Release Date : 2003-03-27
Pharmaceutical Process Validation written by Robert A. Nash and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-03-27 with Medical categories.
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Handbook Of Validation In Pharmaceutical Processes Fourth Edition
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Author : James Agalloco
language : en
Publisher: CRC Press
Release Date : 2021-10-28
Handbook Of Validation In Pharmaceutical Processes Fourth Edition written by James Agalloco and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-28 with Medical categories.
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
Practical Process Validation
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Author : Mark Allen Durivage
language : en
Publisher: Quality Press
Release Date : 2016-07-14
Practical Process Validation written by Mark Allen Durivage and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-07-14 with Business & Economics categories.
For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.