Automation And Validation Of Information In Pharmaceutical Processing
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Automation And Validation Of Information In Pharmaceutical Processing
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Author : Joseph F. deSpautz
language : en
Publisher: CRC Press
Release Date : 1998-06-16
Automation And Validation Of Information In Pharmaceutical Processing written by Joseph F. deSpautz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998-06-16 with Medical categories.
This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operat
Automation And Validation Of Information In Pharmaceutical Processing
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Author : Joseph F. deSpautz
language : en
Publisher: CRC Press
Release Date : 1998-06-16
Automation And Validation Of Information In Pharmaceutical Processing written by Joseph F. deSpautz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998-06-16 with Medical categories.
This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing. Explains how the Food and Drug Administration's latest Good Manufacturing Process guidelines supporting electronic identification and electronic signatures for batch record registration together with computer system technologies will influence pharmaceutical production automation! Designed to provide quick and easy access to a whole range of system development topics, Automation and Validation of Information in Pharmaceutical Processing defines a complete life-cycle methodology that integrates equipment, people, and information presents concepts, guidelines, test plans, example forms, and application details for previously unavailable computer system validation of complex automated information systems introduces, for the first time in depth, PQ testing of integrated manufacturing execution (MES) and manufacturing resource planning (MRP) applications describes how human resource programs maximize productivity gains for automation initiatives discusses approaches to automating batch operations with process control systems using industry examples and applicable computer technology concepts provides an outline for IQ, OQ, and PQ test plans for process control systems, including forms for use in testing instrumentation and distributed control system installation and operations employs a business analysis standpoint on life-cycle planning to justify new automation projects, including multiyear drug manufacturing plans documents the successful application of life-cycle methodologies to supply chain functions and much more! Together with references, tables, and drawings, Automation and Validation of Information in Pharmaceutical Processing is an essential, hands-on resource for pharmaceutical scientists, manufacturers, and engineers; drug quality assurance and regulatory personnel; project and program manufacturers; information system professionals and software developers and analysts; information technology practitioners; and graduate-level and continuing-education students in these disciplines.
Good Manufacturing Practices For Pharmaceuticals
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Author : D. Nally Joseph
language : en
Publisher: CRC Press
Release Date : 2000-10-12
Good Manufacturing Practices For Pharmaceuticals written by D. Nally Joseph and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-10-12 with Medical categories.
Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.
Good Manufacturing Practices For Pharmaceuticals
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Author : Joseph D. Nally
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Good Manufacturing Practices For Pharmaceuticals written by Joseph D. Nally and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
The Pharmaceutical Regulatory Process
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Author : Ira R. Berry
language : en
Publisher: CRC Press
Release Date : 2008-12-02
The Pharmaceutical Regulatory Process 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 2008-12-02 with Medical categories.
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, an
Good Manufacturing Practices For Pharmaceuticals Seventh Edition
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Author : Graham P. Bunn
language : en
Publisher: CRC Press
Release Date : 2019-02-04
Good Manufacturing Practices For Pharmaceuticals Seventh Edition written by Graham P. Bunn and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-02-04 with Medical categories.
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry
Handbook Of Bioseparations
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Author : Satinder Ahuja
language : en
Publisher: Elsevier
Release Date : 2000-06-23
Handbook Of Bioseparations written by Satinder Ahuja and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-06-23 with Technology & Engineering categories.
It is generally recognized that the commercial success of biotechnology products is highly dependent on the successful development and application of high-powered separation and purification methods. In this practical and authoritative handbook, the separation of proteins, nucleic acids, and oligonucleotides from biological matrices is covered from analytical to process scales. Also included in a chapter on the separation of monoclonal antibodies, which have found numerous uses as therapeutic and diagnostic agents. Analytical techniques include an interesting montage of chromatographic methods, capillary electrophoresis, isoelectric focusing, and mass spectrometry. Among separation and purification methods, liquid-liquid distribution, displacement chromatography, expanded bed adsorption, membrane chromatography, and simulated moving bed chromatography are covered at length. Regulatory and economic considerations are addressed, as are plant and process equipment and engineering process control. A chapter on future developments highlights the application of DNA chip arrays as well as evolving methodologies for a large number of drugs that are under development for treatment of cancer, AIDS, rheumatoid arthritis, and Alzheimer's disease. Handbook of Bioseparations serves as an essential reference and guidebook for separation scientists working in the pharmaceutical and biotechnology industries, academia, and government laboratories.Key Features* Covers bioseparations of proteins, nucleic acids, and monoclonal antibodies* Encompasses both analytical and process-scale methods* Elucidates the importance of engineering process control* Details selection of plant and process equipment* Addresses economic considerations* Discusses future developments
Pharmaceutical Process Scale Up
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Author : Michael Levin
language : en
Publisher: CRC Press
Release Date : 2001-12-12
Pharmaceutical Process Scale Up written by Michael Levin and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-12-12 with Medical categories.
Focusing on scientific and practical aspects of process scale-up, this resource details the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale. It covers parenteral and nonparenterel liquids and semi-solids, products derived from biotechnology, dry blending and powder handling,
Water Insoluble Drug Formulation
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Author : Ron Liu
language : en
Publisher: CRC Press
Release Date : 2008-01-18
Water Insoluble Drug Formulation written by Ron Liu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-01-18 with Medical categories.
Scientists have attributed more than 40 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility. Issues surrounding water insolubility can postpone, or completely derail, important new drug development. Even much-needed reformulation of currently marketed products can be significantly affected by these challenges. Water Insolubility is the Primary Culprit in over 40% of New Drug Development Failures The most comprehensive resource on the topic, this second edition of Water Insoluble Drug Formulation brings together a distinguished team of experts to provide the scientific background and step-by-step guidance needed to deal with solubility issues in drug development. Twenty-three chapters systematically describe solubility properties and their impact on formulation, from theory to industrial practice. With detailed discussion on how these properties contribute to solubilization and dissolution, the text also features six brand new chapters on water-insoluble drugs, exploring regulatory aspects, pharmacokinetic behavior, early phase formulation strategies, lipid based systems for oral delivery, modified release of insoluble drugs, and scalable manufacturing aspects. The book includes more than 15 water-insoluble drug delivery systems or technologies, illustrated with case studies featuring oral and parenteral applications. Highlighting the most current information and data available, this seminal volume reflects the significant progress that has been made in nearly all aspects of this field.
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