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Wednesday, June 25, 2014

Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

Book cover Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

Guy Wingate

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

http://bookzz.org/dl/568488/6b98fa

International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries

Book cover International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries

Siri H. Segalstad

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

http://bookzz.org/dl/564390/bc0dd6

Handbook Of Stability Testing In Pharmaceutical Development

Book cover Handbook Of Stability Testing In Pharmaceutical Development

Kim Huynh-Ba

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

http://bookzz.org/dl/563902/37223b

Good Design Practices for GMP Pharmaceutical Facilities

Book cover Good Design Practices for GMP Pharmaceutical Facilities

Andrew Signore, Terry Jacobs

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

http://bookzz.org/dl/563697/97e4a8

Encyclopedia of Pharmaceutical Technology

Book cover Encyclopedia of Pharmaceutical Technology

Swarbrick J., Boylan J. C.

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

http://bookzz.org/dl/563234/2fb02f

Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical GMPs

Book cover Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical GMPs

Food and Drug Administration

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

http://bookzz.org/dl/562544/d914e6

21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Book cover 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Orlando Lopez

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

http://bookzz.org/dl/560842/d4d4d5

HPLC for Pharmaceutical Scientists

Book cover HPLC for Pharmaceutical Scientists

Yuri V. Kazakevich, Rosario LoBrutto

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

http://bookzz.org/dl/550619/e92e57

Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists

Book cover Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists

David G. Watson BSc PhD PGCE

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

http://bookzz.org/dl/509823/7bd27b

Office of Technology Assessment. Pharmaceutical R And D: Costs, Risks And Rewards

Book cover Office of Technology Assessment. Pharmaceutical R And D: Costs, Risks And Rewards

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

http://bookzz.org/dl/463991/a99b35

Enzyme Technologies for Pharmaceutical and Biotechnological Applications

Book cover Enzyme Technologies for Pharmaceutical and Biotechnological Applications

Herbert Kirst, Wu-Kuang Yeh

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

http://bookzz.org/dl/462417/99e137

Thermodynamics of Pharmaceutical Systems: An Introduction for Students of Pharmacy

Book cover Thermodynamics of Pharmaceutical Systems: An Introduction for Students of Pharmacy

Kenneth A. Connors

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

http://bookzz.org/dl/459910/14dc4b

Australian Pharmaceutical Formulary and Handbook

Book cover Australian Pharmaceutical Formulary and Handbook

Pharmaceutical Society of Australia

Year: 2009

Language: English

Pages: 522

http://bookzz.org/dl/1044526/8e7806

Guidelines for Chemical Reactivity Evaluation and Application to Process Design

Book cover Guidelines for Chemical Reactivity Evaluation and Application to Process Design

Center for Chemical Process Safety (CCPS)

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

http://bookzz.org/dl/552497/15238d

Research and Development Management in the Chemical and Pharmaceutical Industry

Book cover Research and Development Management in the Chemical and Pharmaceutical Industry

Peter Bamfield

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

http://bookzz.org/dl/566819/703838

DOE handbook. Chemical management

Book cover DOE handbook. Chemical management

http://bookzz.org/dl/556896/143e96

The chemical laboratory: its design and operation: a practical guide for planners of industrial, medical, or educational facilities

Book cover The chemical laboratory: its design and operation: a practical guide for planners of industrial, medical, or educational facilities

Sigurd Rosenlund

Offers assistance to those involved in planning new laboratories, or expanding existing facilities. Emphasis throughout is on finding economical solutions without sacrificing quality.

http://bookzz.org/dl/594535/51f4b0

Research and Development Management in the Chemical and Pharmaceutical Industry, Second Edition

Book cover Research and Development Management in the Chemical and Pharmaceutical Industry, Second Edition

Dr. Peter Bamfield(auth.)

Year: 2003

Language: English

Pages: 270

http://bookzz.org/dl/2155748/5bcad2

Multi-Plant Safety and Security Management in the Chemical and Process Industries

Book cover Multi-Plant Safety and Security Management in the Chemical and Process Industries

Genserik L.L. Reniers

Year: 2010

Edition: 1

Language: English

http://bookzz.org/dl/1089878/7ec9fa

Framework for Chemical Risk Management under REACH

Book cover Framework for Chemical Risk Management under REACH

Steffen Erler

Year: 2009

Language: English

http://bookzz.org/dl/1084441/a533fe