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One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.
Year: 2000
Edition: 1
Language: English
Pages: 547
Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.
Year: 2008
Edition: 1
Language: English
Pages: 339
Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.
Year: 2008
Edition: 1
Language: English
Pages: 390
A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.
Year: 2005
Edition: 1
Language: English
Pages: 578
This supplement to the Second Edition of the Encyclopedia of Pharmaceutical Technology heralds transformations and advances in the design, development, manufacture, testing, and regulation of pharmaceuticals-supplying over 40 expert-authored articles as well as nearly 1900 new references to groundbreaking research studies.
Part: volume 20
Year: 2001
Language: English
Pages: 335
The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources. They are the perfect low-cost tools for: employees as part of documented GMP training programs, for suppliers/vendors so that they may provide components, labels, and parts with an understanding of FDA requirements, and for each clinical investigator, nurse, and technician to help assure compliance to clinical trial protocols. A keyword index can be found at the end of each booklet.
Year: 2002
Edition: 1
Language: English
Pages: 106
This guide delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with FDA regulations related to international computer validation in the pharmaceutical industry. The guide shows how to comply with computer systems validation requirements, while highlighting and integrating Part 11 requirements into the entire computer validation program. Regulatory compliance is placed within the context of quality assurance, and the importance of integrating validation into the system life cycle using a structured top-down approach is stressed. Information is applicable to computer systems for pharmaceuticals, cosmetics, food, and medical device applications.
Year: 2004
Edition: 1
Language: English
Pages: 287
HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry.
In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided.
This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development.
The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.
Year: 2007
Edition: 1
Language: English
Pages: 1135
Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists highlights the most important aspects of a wide range of techniques used in the control of the quality of pharmaceuticals, including spectroscopy, chromatography, and electrophoresis. This clear, practical guide also includes self-testing sections and arithmetical examples and tests to help students brush up on their arithmetical skills in an applied context.
Part: Volume 4
Year: 1999
Language: English
Pages: 338
Pharmaceutical costs are among the fastest growing components of health care costs today. Although increases in the inflation-adjusted prices of ethical drugs and perceived high prices of new drugs have been a concern of congressional committees for over 30 years, the growing Federal role in paying for prescription drugs has increased the concern over the appropriateness of prices relative to the costs of bringing new drugs to market. Specific policies of U.S. and other governments can alter the delicate balance between costs and returns to pharmaceutical R&D. with ramifications for the future health of Americans, for health care costs, and for the future of the U.S. pharmaceutical industry.OTA's report focuses mainly on the economic side.
Year: 2005
Language: English
Pages: 359
This reference provides a review of enzyme functions in human and animal health. It covers basic principles and applications in antibiotic biosynthesis, biocatalysis, and screening and assay optimization, as well as new and emerging technologies in the biotechnological and pharmaceutical industries. Emphasizing modern methods of metabolic engineering and drug discovery processes, the book details enzyme targets related to human disease. It also discusses effective enzymatic assays, high-throughput screening, novel compounds for lead generation, improvements in antibiotic yield, and the generation of contemporary protein products.
Year: 2001
Edition: 1
Language: English
Pages: 628
Studies of thermodynamics often fail to demonstrate how the mathematical intricacies of the subject relate to practical laboratory applications. Thermodynamics of Pharmaceutical Systems makes these connections clear, emphasizing specific applications to pharmaceutical systems in a study created specifically for contemporary curriculums at colleges of pharmacy.Students investigating drug discovery, drug delivery, and drug action will benefit from Kenneth Connors's authoritative treatment of the fundamentals of thermodynamics as well as his attention to drug molecules and experimental considerations. An extensive appendix that reviews the mathematics needed to master the pharmacy curriculum proves an invaluable reference. Connors divides his one-of-a-kind text into three sections: Basic Thermodynamics, Thermodynamics of Physical Processes, and Thermodynamics of Chemical Processes; chapters include: * Energy and the First Law of Thermodynamics * The Entropy Concept * Phase Transformations * Solubility * Acid-Base Equilibria * Noncovalent Binding EquilibriaThermodynamics need not be a mystery nor be confined to the realm of mathematical theory. Thermodynamics of Pharmaceutical Systems introduces students of pharmacy to the profound thermodynamic applications in the laboratory while also serving as a handy resource for practicing researchers.
Year: 2002
Language: English
Pages: 346
Drawn from international sources, this book provides principles and strategies for the evaluation of chemical reactions, and for using this information in process design and management. A useful resource for engineers who design, start-up, operate, and manage chemical and petrochemical plants, the book places special emphasis on the use of state-of-the-art technology in theory, testing methods, and applications in design and operations.
Year: 1995
Language: English
Pages: 247
Mastering management skills is hard to achieve by newcomers starting their careers in the chemical industry. The message coming from there is that good chemists swiftly have to become good managers if they are to survive and progress in today's competitive climate.This book is designed to help guide younger R & D chemists to ways in which they can quickly evolve skills which are built around three factors-people, knowledge and time. It covers the management of scientific personnel, management within a variety of R & D organisational structures, creating a climate of innovation, the management of projects including the time management and communication aspects of the job.The author, Peter Bamfield, is now working as a consultant. Due to his long experience in the chemical industry, he was elected President of the Royal Society of Chemistry's Industrial Affairs Division.This second edition of the book has been revised and updated to take recent global developments and restructuring in the chemical industry into account, as well as the rising importance of information technology in management.
Year: 2003
Edition: 2
Language: English
Pages: 280
Offers assistance to those involved in planning new laboratories, or expanding existing facilities. Emphasis throughout is on finding economical solutions without sacrificing quality.
Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams. Moreover, this reference provides guidance on:Directing and carrying out specific tasks and courses of actionMaking and communicating clear and achievable decisionsSolving problems on the spotManaging the administrative aspects of chemical process developmentThe author, Dr. Derek Walker, has directed chemical process development work for four decades, combining firsthand chemical synthesis experience with many other disciplines needed to create chemical processes. You will benefit from his advice and unique insights into:Understanding the workings of matrix organizationsDefining missions and creating action plansDeveloping interdisciplinary approaches to problem solvingHolding review meetings, revising goals, and motivating staffPrioritizing programs and responses to emergenciesIn addition, you'll learn how successful chemists, in collaboration with other disciplines, define the best (green) chemistry for process scale-up, including accommodating FDA requirements in the last process steps and addressing safety and environmental matters early in their work. Case studies provide incisive perspective on these issues. A chapter on recognizing and patenting intellectual property emphasizes the importance of comprehensive literature surveys and understanding invention. A chapter on the future challenges you to think beyond narrow constraints and explore new horizons.
Year: 2003
Edition: 1
Language: English
Pages: 416
Operational Risk Management offers peace of mind to business and government leaders who want their organizations to be ready for any contingency, no matter how extreme. This invaluable book is a preparatory resource for when times are good, and an emergency reference when times are bad. Operational Risk Management is destined to become every risk manager?s ultimate weapon to help his or her organization survive ? no matter what.
Year: 2005
Edition: 1
Language: English
Pages: 278
Over the years, companies have developed independent systems for managing process safety, environment, health, safety, and quality. Many aspects of these management systems are similar. Integrating EHS management systems can yield economies and improved system effectiveness. This book explains how integration reduces cost of delivery through a reduction in the number of management program steps and avoidance of redundancy; how it results in more effective programs, since the best practices can be combined into a single process; and how this integration brings a faster, and more cost effective response to new demands.
Year: 1996
Language: English
Pages: 192
