Pharmaceutical Manufacturing Products

  • Microbiological Contamination Control in Pharmaceutical Clean Rooms

    1st Edition

    Edited by Nigel Halls

    Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it…

    Hardback – 2004-06-25
    CRC Press

  • Microbial Contamination Control in Parenteral Manufacturing

    1st Edition

    By Kevin Williams

    This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean…

    Hardback – 2004-05-20
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Supercritical Fluid Technology for Drug Product Development

    1st Edition

    Edited by Peter York, Uday B. Kompella, Boris Y. Shekunov

    Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their current and anticipated utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications, this volume unlocks the potential of supercritical fluids to…

    Hardback – 2004-03-23
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • 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

  • Biomarkers in Clinical Drug Development

    1st Edition

    Edited by John Bloom, Richard A. Dean

    Presenting applications in clinical development, pharmacokinetic/ pharmacodynamic modelling and clinical trial simulation, this reference studies the role of biomarkers in successful drug formulation and development.…

    Hardback – 2003-05-20
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Quality Rules in Packaging

    Revised American Edition, 5-pack, 1st Edition

    By John Sharp

    This newly-revised and specifically American edition of the best-selling original is the perfect introduction to drug packaging Good Manufacturing Practice (GMP). It is the ideal training resource for workers recently hired into the pharmaceutical, chemical, biotechnology, and bulk pharmaceutical…

    Pack – 2002-06-30
    CRC Press

  • Pharmaceutical Master Validation Plan

    The Ultimate Guide to FDA, GMP, and GLP Compliance, 1st Edition

    By Syed Imtiaz Haider

    The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that…

    Hardback – 2001-12-27
    CRC Press

  • Sterile Filtration

    A Practical Approach, 1st Edition

    By Maik W. Jornitz, Theodore H. Meltzer

    This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals.Addresses the complexities…

    Hardback – 2000-12-18
    CRC Press

  • Pharmaceutical Packaging Technology

    1st Edition

    Edited by D. A. Dean, E. R. Evans, I. H. Hall

    Pharmaceutical packaging requires a greater knowledge of materials and a greater intensity of testing than most other packed products, not to mention a sound knowledge of pharmaceutical products and an understanding of regulatory requirements. Structured to meet the needs of the global market, this…

    Hardback – 2000-11-30
    CRC Press

  • Control of Particulate Matter Contamination in Healthcare Manufacturing

    1st Edition

    By Thomas A. Barber

    This book offers practical applications addressing the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality considerations. Written by an industry expert, this material offers a clear and concise understanding…

    Hardback – 1999-10-31
    CRC Press

  • How to Develop and Manage Qualification Protocols for FDA Compliance

    1st Edition

    By Phil Cloud

    All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation document be established and followed. Yet these regulations do not provide guidelines on how to produce documentation such…

    Hardback – 1999-08-31
    CRC Press

  • Pharmaceutical Equipment Validation

    The Ultimate Qualification Guidebook, 1st Edition

    By Phil Cloud

    While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use…

    Hardback – 1998-08-31
    CRC Press

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