Analysis & Pharmaceutical Quality Products

  • Photostability of Drugs and Drug Formulations

    2nd Edition

    Edited by Hanne Hjorth Tonnesen

    Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with…

    Hardback – 2004-06-29
    CRC Press

  • Facility Validation

    Theory, Practice, and Tools, 1st Edition

    By Graham C. Wrigley

    Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress. Thoroughly defining the philosophy, application, and processes,…

    Hardback – 2004-03-29
    CRC Press

  • Clinical Studies Management

    A Practical Guide to Success, 1st Edition

    By Simon Cook

    What if you were suddenly in charge? After the initial excitement of a "battlefield promotion" wears off, you need to get in the trenches and get the job done. And if you are already in the trenches, you need quick access to information that will make your job easier. A comprehensive desk reference…

    Hardback – 2004-01-15
    CRC Press

  • 21 CFR Part 11

    Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry, 1st Edition

    By Orlando López

    Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies…

    Hardback – 2004-01-15
    CRC Press

  • Electronic Record Keeping

    Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164, 1st Edition

    By David Nettleton, Janet Gough

    The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic…

    Hardback – 2003-12-29
    CRC Press

  • Computer Systems Validation

    Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies, 1st Edition

    Edited by Guy Wingate

    Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it…

    Hardback – 2003-12-18
    CRC Press

  • Microbiological Assay for Pharmaceutical Analysis

    A Rational Approach, 1st Edition

    By William Hewitt

    A user-friendly guide for the evaluation of microbiological assays, Microbiological Assay for Pharmaceutical Analysis: A Rational Approach provides a lucid explanation of the sources of error in microbiological assay and helps analysts choose efficient assay designs that will minimize those…

    Hardback – 2003-12-15
    CRC Press

  • Pharmaceutical Engineering Change Control

    2nd Edition

    Edited by Simon G. Turner

    Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and…

    Hardback – 2003-12-15
    CRC Press

  • Testing Computers Systems for FDA/MHRA Compliance

    1st Edition

    By David Stokes

    There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals…

    Hardback – 2003-11-25
    CRC Press

  • GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)

    1st Edition

    By Leonard Steinborn

    Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT…

    Hardback – 2003-06-27
    CRC Press

  • Pharmaceutical Process Validation

    An International, 3rd Edition

    Edited by Robert A. Nash, Alfred H. Wachter

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

    Hardback – 2003-03-27
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Rapid Microbiological Methods in the Pharmaceutical Industry

    1st Edition

    Edited by Martin C. Easter

    In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and,…

    Hardback – 2003-03-19
    CRC Press

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