Equipment Qualification in the Pharmaceutical Industry Book

Equipment Qualification in the Pharmaceutical Industry


  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release Date : 2019-06-13
  • Genre: Business & Economics
  • Pages : 234
  • ISBN 10 : 9780128175699
  • Total Read : 71
  • File Size : 13,5 Mb

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Equipment Qualification in the Pharmaceutical Industry Summary:

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. Incorporates good manufacturing processes into a compliant qualification program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

Pharmaceutical Equipment Validation Book

Pharmaceutical Equipment Validation


  • Author : Phil Cloud
  • Publisher : CRC Press
  • Release Date : 1998-08-31
  • Genre: Medical
  • Pages : 456
  • ISBN 10 : 1574910795
  • Total Read : 77
  • File Size : 7,8 Mb

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Pharmaceutical Equipment Validation Summary:

While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.

Handbook of Validation in Pharmaceutical Processes  Fourth Edition Book

Handbook of Validation in Pharmaceutical Processes Fourth Edition


  • Author : James Agalloco
  • Publisher : CRC Press
  • Release Date : 2021-10-28
  • Genre: Medical
  • Pages : 1061
  • ISBN 10 : 9781000436013
  • Total Read : 93
  • File Size : 10,7 Mb

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Handbook of Validation in Pharmaceutical Processes Fourth Edition Summary:

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

How to Validate a Pharmaceutical Process Book

How to Validate a Pharmaceutical Process


  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release Date : 2016-06-07
  • Genre: Medical
  • Pages : 218
  • ISBN 10 : 9780128096536
  • Total Read : 61
  • File Size : 14,7 Mb

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How to Validate a Pharmaceutical Process Summary:

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

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing Book
Score: 4
From 1 Ratings

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing


  • Author : Hamid Mollah
  • Publisher : John Wiley & Sons
  • Release Date : 2013-03-18
  • Genre: Science
  • Pages : 432
  • ISBN 10 : 9780470552346
  • Total Read : 85
  • File Size : 16,9 Mb

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Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing Summary:

Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Pharmaceutical Process Validation Book

Pharmaceutical Process Validation


  • Author : Bernard T. Loftus
  • Publisher : Marcel Dekker Incorporated
  • Release Date : 1984
  • Genre: Medical
  • Pages : 322
  • ISBN 10 : UOM:39015006032687
  • Total Read : 68
  • File Size : 13,8 Mb

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Pharmaceutical Process Validation Summary:

Validation of Pharmaceutical Processes Book
Score: 4
From 5 Ratings

Validation of Pharmaceutical Processes


  • Author : James P. Agalloco
  • Publisher : CRC Press
  • Release Date : 2007-09-25
  • Genre: Medical
  • Pages : 760
  • ISBN 10 : 9781420019797
  • Total Read : 59
  • File Size : 19,7 Mb

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Validation of Pharmaceutical Processes Summary:

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

Good Design Practices for GMP Pharmaceutical Facilities Book

Good Design Practices for GMP Pharmaceutical Facilities


  • Author : Terry Jacobs
  • Publisher : CRC Press
  • Release Date : 2016-08-19
  • Genre: Medical
  • Pages : 535
  • ISBN 10 : 9781482258912
  • Total Read : 89
  • File Size : 17,5 Mb

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Good Design Practices for GMP Pharmaceutical Facilities Summary:

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.