Analysis & Pharmaceutical Quality Products

  • GMP Compliance, Productivity, and Quality

    Achieving Synergy in Healthcare Manufacturing, 1st Edition

    Edited by Vinay Bhatt

    Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from…

    Hardback – 1998-06-30
    CRC Press

  • Automation and Validation of Information in Pharmaceutical Processing

    1st Edition

    By Joseph F. deSpautz

    This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for…

    Hardback – 1998-06-16
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Validation Fundamentals

    How to, What to, When to Validate, 1st Edition

    By William Gibson, Keith Powell-Evans

    Written by the founders of the Institute of Validation, this practical introduction to validation cuts through all the jargon and focuses on the essentials. Whether you are a novice or an experienced validator, this book will help you understand validation fundamentals and ways in which these…

    Hardback – 1998-04-30
    CRC Press

  • Validation for Medical Device and Diagnostic Manufacturers

    2nd Edition

    By Carol V. Desain, Charmaine V. Sutton

    Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is…

    Hardback – 1997-09-30
    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…

    Hardback – 1997-07-31
    CRC Press

  • Biotechnology of Antibiotics

    2nd Edition

    Edited by William Strohl

    This incomparable Second Edition of a highly regarded reference has been entirely rewritten and enlarged to reflect the explosion of information and technologies that have emerged since the publication of the previous edition.Strikes the perfect balance between proven traditional approaches and…

    Hardback – 1997-07-03
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Pre-Production Quality Assurance for Healthcare Manufacturers

    1st Edition

    By G. William Hough, David A. Rawlings, Michael F. Turner

    The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product…

    Hardback – 1997-06-30
    CRC Press

  • Software Quality Assurance

    A Guide for Developers and Auditors, 1st Edition

    By Howard T. Garst Smith

    Of all the audit functions faced by QA, software auditing is probably the most difficult because of the need to know and understand the intricacies of the processes being audited. In addition, auditors must be familiar with and understand the implications of the international and national standards…

    Hardback – 1997-06-30
    CRC Press

  • Pharmaceutical Dosage Forms

    Disperse Systems, 2nd Edition

    Edited by Herbert Lieberman, Martin Rieger, Gilbert S. Banker

    Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this Second Edition of a well-received reference test highlights typical formulations, the avoidance of formulation pitfalls, and compliance with established regulatory principles.…

    Hardback – 1996-05-16
    CRC Press

  • Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries

    1st Edition

    By R. Baird, Sally F. Bloomfield

    The importance of quality assurance in the production, storage and use of manufactured preparations is widely recognized. This book encapsulates the issues involved in the manufacture of non-steriles, such as creams, ointments, herbal remedies, shampoos, soaps and toiletry products (as opposed to…

    Hardback – 1996-05-01
    CRC Press

  • Automated Microbial Identification and Quantitation

    Technologies for the 2000s, 1st Edition

    Edited by Wayne P. Olson

    This book focuses on practical, proven applications to automate the microbial identification process economically and with greater levels of safety and quality for patients. A diverse group of recognized experts survey the topic and present the latest techniques and technologies for microbial…

    Hardback – 1996-01-31
    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…

    Hardback – 1995-05-31
    CRC Press

Product Search