May/June 2014
Volume 34, Number 3


    Supply Chain Management

    A Changing Landscape: Perspectives on Temperature Management for the Distribution of Non-Refrigerated Clinical Supplies Description
    by Dr. Nicole Assfalg, Ted Bradley, Tim Brewer, Sébastien Delporte, Kristen DeVito, Bruce Guenter, and Patricia Thomas
    This article discusses the shipment of room temperature products from several perspectives: the changing regulatory environment, risk assessment and mitigation, new technologies and budgetary pressures.
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    Patient Centric Innovations in the Clinical Supply Chain
    by Karen Gram, Hans Heesakkers, Roger Lauwers, and Sascha Sonnenberg
    This article discusses the use of Just in Time (JIT) and E-labeling to minimize supply chain problems and increase the safety of subjects in a clinical trial.
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    Change Notifications for Single Use Components: Criteria from an End User Perspective
    by Sally Kline, Ekta Mahajan, Darrell Morrow, Bob Steininger, Nancy Sweeney, and Russell Wong*
    *All authors contributed equally to this article.
    This article presents science and risk-based approaches to categorize levels of changes in Single Use Systems (SUS) raw material and manufacturing processes.
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    How Does Strategic Planning Help to Mitigate Risks in the Pharmaceutical Supply Chain
    by Agnes Trouchaud
    This article presents the implementation of a key strategic planning process to mitigate risks in GSK’s API supply chain; it was adapted from an ISPE France presentation held in June 2013.
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    How Does Strategic Planning Help to Mitigate Risks in the Pharmaceutical Supply Chain - Diagram
    by Agnes Trouchaud

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    Facilities and Equipment

    Transfer Station Design for Large Scale API Manufacture (Part One)
    by Joseph R. Hettenbach, PE
    This article presents Part One of a two part article describing the background bases and philosophies applied to the development of detailed layout of process manifold rooms and of the process service rooms.
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    Defining Holistic Asset Criticality to Manage Risk
    by David J. Mierau, PE, CMRP
    This article presents how risks to safety, quality and productivity can be managed through asset control strategies, which are created based on specific asset criticality and failure modes.
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    Research and Development

    To Investigate the Antimicrobial Potential of Lucilia sericata Larvae
    by Qin Xiang Ng
    This article presents a research project that investigates the antimicrobial effects of excretions/secretions and gas flatulence produced by Lucilia sericata larvae on Escherichia coli, Staphylococcus epidermidis, and Micrococcus luteus. It was presented at the 2013 ISPE Annual Meeting as part of the student poster competition.
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    Regulatory Compliance

    Global Regulatory News

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    Also Inside

    From the Editor
    by Gloria Hall, Editor, Pharmaceutical Engineering

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    ISPE Update
    FOYA – Celebrating 10 Years; ISPE Concept Paper: Improving Access for Patients with Unmet Medical Needs; GAMP Good Practice Guide – A Risk Based Approach to Regulated Mobile Applications; Maintaining Data Integrity and Reducing Patient Risk; Did You Know? You Can Try ISPE’s Expanded eLearning for Free; Step up your Knowledge in Barcelona
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    Classified Advertising with Advertiser’s Index

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    President's Message

    ISPE – Your Most Strategic Career Asset
    by Nancy Berg, ISPE President/CEO
    Berg discusses how ISPE is helping Members gain knowledge and exposure to new ideas, methods and perspectives through a wide array of programs, activities and publications.
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    NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2014 ISPE. All rights reserved.)

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