Analysis & Pharmaceutical Quality Products

  • GLP Quality Audit Manual

    3rd Edition

    By Milton A. Anderson

    Designed to enable readers to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing…

    Paperback – 2019-12-20 
    CRC Press

  • Validation Standard Operating Procedures

    A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, 2nd Edition

    By Syed Imtiaz Haider

    Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production.…

    Paperback – 2019-12-20 
    CRC Press

  • Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

    1st Edition

    Edited by Rosamund M. Baird, Norman A. Hodges, Stephen P. Denyer

    Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control…

    Paperback – 2019-10-10
    CRC Press

  • GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)

    Regulations, Standards, and Guidelines, 6th Edition

    By Leonard Steinborn

    This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished…

    Paperback – 2019-10-10
    CRC Press

  • Validating Pharmaceutical Systems

    Good Computer Practice in Life Science Manufacturing, 1st Edition

    Edited by John Andrews

    All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements…

    Paperback – 2019-10-07
    CRC Press

  • Validation of Computerized Analytical Systems

    1st Edition

    By Ludwig Huber

    Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control…

    Paperback – 2019-10-07
    CRC Press

  • Validating Corporate Computer Systems

    Good IT Practice for Pharmaceutical Manufacturers, 1st Edition

    Edited by 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…

    Paperback – 2019-09-23
    CRC Press

  • Laboratory Auditing for Quality and Regulatory Compliance

    1st Edition

    By Donald C. Singer, Raluca-Ioana Stefan, Jacobus F. van Staden

    Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.…

    Paperback – 2019-09-23
    CRC Press

  • 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…

    Paperback – 2019-09-19
    CRC Press

  • Biotechnology

    Quality Assurance and Validation, 1st Edition

    Edited by Kenneth E. Avis, Carmen M. Wagner, Vincent L. Wu

    Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique…

    Paperback – 2019-09-11
    CRC Press

  • Quality and GMP Auditing

    Clear and Simple, 1st Edition

    By James L. Vesper

    This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along…

    Paperback – 2019-09-05
    CRC Press

  • The Pharmaceutical Regulatory Process

    2nd Edition

    Edited by Ira R. Berry, Robert P. Martin

    This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by…

    Paperback – 2019-06-07
    CRC Press
    Drugs and the Pharmaceutical Sciences

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