Analysis & Pharmaceutical Quality Products

  • Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

    By Syed Imtiaz Haider, Erfan Syed Asif

    To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for…

    Hardback – 2012-06-05
    CRC Press

  • Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

    Edited by Anurag S. Rathore, Gail Sofer

    Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as…

    Hardback – 2012-05-08
    CRC Press
    Biotechnology and Bioprocessing

  • Dietary Supplement Good Manufacturing Practices

    Preparing for Compliance

    By William J. Mead

    Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products. The recent regulations, outlining broad goals, intentionally avoid specifics to allow…

    Hardback – 2011-11-16
    CRC Press

  • Pharmaceutical Stress Testing

    Predicting Drug Degradation, Second Edition

    Edited by Steven W. Baertschi, Karen M. Alsante, Robert A. Reed

    The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The…

    Hardback – 2011-07-26
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Quality Control Training Manual

    Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

    By Syed Imtiaz Haider, Syed Erfan Asif

    Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses…

    Hardback – 2011-02-15
    CRC Press

  • Pharmaceutical Process Scale-Up, Third Edition

    Edited by Michael Levin

    The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that…

    Hardback – 2011-02-01
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Pharmaceutical Water

    System Design, Operation, and Validation, Second Edition

    By William V. Collentro

    A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries—used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. Drawing on the author’s extensive field…

    Hardback – 2010-12-20
    CRC Press

  • Pharmaceutical Dosage Forms - Parenteral Medications, Third Edition

    Volume 2: Facility Design, Sterilization and Processing

    Edited by Sandeep Nema, John D. Ludwig

    This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it…

    Hardback – 2010-08-25
    CRC Press

  • Pharmaceutical Dosage Forms - Parenteral Medications, Third Edition

    Volume 1: Formulation and Packaging

    Edited by Sandeep Nema, Sandeep Nema, John D. Ludwig, John D. Ludwig

    This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it…

    Pack - Book & Ebook – 2010-08-25
    CRC Press

  • Sterile Drug Products

    Formulation, Packaging, Manufacturing and Quality

    By Michael J. Akers

    Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions,…

    Hardback – 2010-08-19
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Advanced Aseptic Processing Technology

    Edited by James Agalloco, James Akers

    The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing…

    Hardback – 2010-07-22
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Pharmaceutical Computer Systems Validation

    Quality Assurance, Risk Management and Regulatory Compliance, 2nd Edition

    Edited by Guy Wingate

    Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements…

    Hardback – 2010-02-22
    CRC Press

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