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Analysis & Pharmaceutical Quality Books

You are currently browsing 1–10 of 98 new and published books in the subject of Analysis & Pharmaceutical Quality — sorted by publish date from newer books to older books.

For books that are not yet published; please browse forthcoming books.

New and Published Books

  1. 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...

    Published June 6th 2012 by CRC Press

  2. Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

    Edited by Anurag S. Rathore, Gail Sofer

    Series: Biotechnology and Bioprocessing

    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...

    Published May 9th 2012 by CRC Press

  3. 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...

    Published November 17th 2011 by CRC Press

  4. Pharmaceutical Stress Testing

    Predicting Drug Degradation, Second Edition

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

    Series: Drugs and the Pharmaceutical Sciences

    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...

    Published July 27th 2011 by CRC Press

  5. 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...

    Published February 16th 2011 by CRC Press

  6. Pharmaceutical Process Scale-Up, Third Edition

    Edited by Michael Levin

    Series: Drugs and the Pharmaceutical Sciences

    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...

    Published February 2nd 2011 by CRC Press

  7. 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...

    Published December 21st 2010 by CRC Press

  8. 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...

    Published August 26th 2010 by CRC Press

  9. Pharmaceutical Dosage Forms - Parenteral Medications, Third Edition

    Volume 1: Formulation and Packaging

    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...

    Published August 26th 2010 by CRC Press

  10. Sterile Drug Products

    Formulation, Packaging, Manufacturing and Quality

    By Michael J. Akers

    Series: Drugs and the Pharmaceutical Sciences

    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,...

    Published August 20th 2010 by CRC Press