Handbook Of Validation In Pharmaceutical Processes Fourth Edition

Author : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publisher : CRC Press
Page : 1062 pages
File Size : 51,9 Mb
Release : 2021-10-28
Category : Medical
ISBN : 9781000436013

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Handbook of Validation in Pharmaceutical Processes, Fourth Edition by James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell Pdf

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 : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publisher : CRC Press
Page : 1043 pages
File Size : 46,5 Mb
Release : 2021-10
Category : Medical
ISBN : 1003163130

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Handbook of Validation in Pharmaceutical Processes, Fourth Edition by James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell Pdf

"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"--

Author : James P. Agalloco,Frederick J. Carleton
Publisher : CRC Press
Page : 760 pages
File Size : 53,6 Mb
Release : 2007-09-25
Category : Medical
ISBN : 9781420019797

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Validation of Pharmaceutical Processes by James P. Agalloco,Frederick J. Carleton Pdf

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

Author : Steven Ostrove
Publisher : Academic Press
Page : 218 pages
File Size : 49,5 Mb
Release : 2016-06-07
Category : Medical
ISBN : 9780128096536

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How to Validate a Pharmaceutical Process by Steven Ostrove Pdf

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

Author : Lynn D. Torbeck
Publisher : Unknown
Page : 200 pages
File Size : 50,5 Mb
Release : 2010
Category : Experimental design
ISBN : 193372238X

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Validation by Design by Lynn D. Torbeck Pdf

Author : Phillip A. Cloud
Publisher : Unknown
Page : 443 pages
File Size : 41,8 Mb
Release : 1998
Category : MEDICAL
ISBN : 0367802996

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Pharmaceutical Equipment Validation by Phillip A. Cloud Pdf

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.

Author : Frederick J. Carleton,James P. Agalloco
Publisher : Marcel Dekker
Page : 728 pages
File Size : 48,7 Mb
Release : 1986
Category : Medical
ISBN : UOM:39015010137415

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Validation of Aseptic Pharmaceutical Processes by Frederick J. Carleton,James P. Agalloco Pdf

Author : Bernard T. Loftus,Robert A. Nash
Publisher : Marcel Dekker
Page : 320 pages
File Size : 48,7 Mb
Release : 1984
Category : Business & Economics
ISBN : UOM:39015006032687

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Pharmaceutical Process Validation by Bernard T. Loftus,Robert A. Nash Pdf

Author : Joachim Ermer,Phil W. Nethercote
Publisher : John Wiley & Sons
Page : 440 pages
File Size : 44,7 Mb
Release : 2014-08-27
Category : Medical
ISBN : 9783527672189

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Method Validation in Pharmaceutical Analysis by Joachim Ermer,Phil W. Nethercote Pdf

This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

Author : Ira R. Berry,Robert A. Nash
Publisher : CRC Press
Page : 658 pages
File Size : 55,5 Mb
Release : 1993-01-29
Category : Medical
ISBN : UOM:39015029467159

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Pharmaceutical Process Validation, Second Edition by Ira R. Berry,Robert A. Nash Pdf

The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 857 pages
File Size : 45,9 Mb
Release : 2008-04-04
Category : Science
ISBN : 9780470259825

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Pharmaceutical Manufacturing Handbook by Shayne Cox Gad Pdf

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 : James Robar
Publisher : CRC Press
Page : 255 pages
File Size : 43,7 Mb
Release : 2024-07-05
Category : Medical
ISBN : 9781040038185

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3D Printing in Radiation Oncology by James Robar Pdf

3D Printing in Radiation Oncology: Personalization of Patient Treatment Through Digital Fabrication presents a comprehensive and practical view of the many forms in which 3D printing is being integrated into radiation oncology practice. Radiation oncology employs among the most sophisticated digital technologies in medicine. Until recently, however, the “last mile” of treatment has required manually produced or generic devices for patient set up, positioning, control of surface dose, and delivery of brachytherapy treatment. 3D printing is already offering enhancements in both precision and efficiency through the digital design and fabrication of patient photon and electron bolus, customized surface and gynecological brachytherapy applicators, proton beam compensators and range shifters, patient immobilization, novel radiation detectors, and phantoms. Various innovations are disrupting decades-old practices in radiation therapy (RT) facilities, resulting in vital improvements in personalization of treatment and patient experience. An essential read for radiation oncologists, medical physicists, radiation therapists, oncology nurses, hospital administrators, engineers, and medical educators, this book is an indispensable resource for those bringing 3D printing to the RT clinic, looking to expand the role of 3D printing in their practice, or embarking upon related research and development.

Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Page : 298 pages
File Size : 52,7 Mb
Release : 2019-04-15
Category : Medical
ISBN : 9780128094129

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Principles of Parenteral Solution Validation by Igor Gorsky,Harold S. Baseman Pdf

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Author : Michael E. Swartz,Ira S. Krull
Publisher : CRC Press
Page : 226 pages
File Size : 48,5 Mb
Release : 2012-04-24
Category : Science
ISBN : 9780824706890

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Handbook of Analytical Validation by Michael E. Swartz,Ira S. Krull Pdf

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.

Author : Steven Ostrove
Publisher : Academic Press
Page : 234 pages
File Size : 44,6 Mb
Release : 2019-06-13
Category : Business & Economics
ISBN : 9780128175699

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Equipment Qualification in the Pharmaceutical Industry by Steven Ostrove Pdf

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