Validation Of Pharmaceutical Processes

Author : James P. Agalloco,Frederick J. Carleton
Publisher : CRC Press
Page : 762 pages
File Size : 42,6 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 : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publisher : CRC Press
Page : 1062 pages
File Size : 44,5 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 : Steven Ostrove
Publisher : Academic Press
Page : 218 pages
File Size : 42,8 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 : Robert A. Nash,Alfred H. Wachter
Publisher : CRC Press
Page : 776 pages
File Size : 40,7 Mb
Release : 2003-03-27
Category : Medical
ISBN : 0824708385

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Pharmaceutical Process Validation by Robert A. Nash,Alfred H. Wachter Pdf

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

Author : Joachim Ermer,John H. McB. Miller
Publisher : John Wiley & Sons
Page : 418 pages
File Size : 41,5 Mb
Release : 2006-03-06
Category : Science
ISBN : 9783527604470

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Method Validation in Pharmaceutical Analysis by Joachim Ermer,John H. McB. Miller Pdf

Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

Author : Anurag S. Rathore,Gail Sofer
Publisher : CRC Press
Page : 535 pages
File Size : 48,6 Mb
Release : 2012-05-09
Category : Medical
ISBN : 9781439850930

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Process Validation in Manufacturing of Biopharmaceuticals, Third Edition by Anurag S. Rathore,Gail Sofer Pdf

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Author : Frederick J. Carleton,James P. Agalloco
Publisher : Marcel Dekker
Page : 728 pages
File Size : 52,9 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 : 44,8 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 : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Page : 300 pages
File Size : 53,9 Mb
Release : 2019-11-27
Category : Medical
ISBN : 9780128094464

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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 : Ira R. Berry,Robert A. Nash
Publisher : CRC Press
Page : 658 pages
File Size : 43,9 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 : James P. Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publisher : Unknown
Page : 128 pages
File Size : 51,5 Mb
Release : 2022
Category : Pharmaceutical technology
ISBN : 0367756064

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Handbook of Validation in Pharmaceutical Processes by James P. 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 : Destin A. LeBlanc
Publisher : CRC Press
Page : 216 pages
File Size : 47,7 Mb
Release : 2022-12-20
Category : Medical
ISBN : 9781000835595

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Cleaning Validation by Destin A. LeBlanc Pdf

Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Features • Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. • The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. • Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. • A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.

Author : Guy Wingate
Publisher : CRC Press
Page : 773 pages
File Size : 49,7 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420088953

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Pharmaceutical Computer Systems Validation by Guy Wingate Pdf

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 : Unknown
Page : 204 pages
File Size : 41,9 Mb
Release : 2019-03-25
Category : Electronic
ISBN : 1946964174

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ISPE Good Practice Guide by Ispe Pdf

Author : Orlando Lopez
Publisher : Taylor & Francis
Page : 326 pages
File Size : 52,8 Mb
Release : 2018-10-02
Category : Business & Economics
ISBN : 9781351704342

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Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation by Orlando Lopez Pdf

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.