September/October 2009
Volume 29, Number 5



    Trends in Pharmaceutical Manufacturing – Key Issues When Deciding to Outsource
    by Takayuki Kasai
    This article presents key issues in regard to pharmaceutical contract manufacturing.
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    Change Management during Offshore Outsourcing: Success Factors for Implementation
    by Dr. T. R. Ramanathan
    This article discusses the nature of organizational change with respect to offshore outsourcing of IT activities in the different Information Systems Departments (ISDs) of a global pharmaceutical company and examines the effectiveness of approaches used to manage this change.
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    Applied Quality Risk Management: Case Study – Laboratory Computerized Systems
    by Ms. Judith Samardelis, Ms. Winnie Cappucci
    This article discusses how to apply the GAMP 5 quality risk management strategy to maintain compliance in laboratory computerized systems.
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    Enhancing Delivery of Complex Facilities with Building Information Modeling (BIM) Technology
    by Mr. Andrew Signore, Mr. Stephen Franey
    This article will describe Building Information Modeling (BIM), provide several real-world examples of the advantages that owners have experienced when their projects were designed and developed with BIM, and offer suggestions for minimizing risks and maximizing BIM’s benefits.
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    PAT Tools for the Optimization of the Freeze-Drying Process
    by Davide Fissore, Mr. Miquel Galan, Roberto Pisano, Salvatore Velardi, Mr. Antonello Barresi
    This article presents an innovative system for in-line process monitoring and control of freeze-drying pharmaceuticals in vials. This system is demonstrated to avoid drying failure in a wide range of operating conditions, as well as to minimize the duration of primary drying.
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    Building a Flexible, Cost-Efficient Global Supply Chain
    by Simon Kaye
    This article presents new developments in global sourcing logistics and demonstrates how pharmaceutical producers can build an integrated supply and product development strategy.
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    Industry Interview Series: President and CEO, International Society for Pharmaceutical Engineering, Bob Best
    ISPE’s President reflects on the past 25 years of the Society’s incredible history and discusses the challenge to become truly global; the importance of becoming a trusted technical resource for Members and regulators; and positioning the Society for success in the future.
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    Global Regulatory News

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    ISPE Update

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    Classified Advertising with Advertiser’s Index

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    Online Exclusive Articles

    China Pharmaceutical Intellectual Property Protection Reform – Review of the Medicine-Patent Related Provisions in the Draft Patent Law of the People's Republic of China
    by Dong Zuojun, Huang Wenlong
    This article presents patent, genetic resources, medicines compulsory licensing, parallel importation, and bolar exceptions.
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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 © 2009 ISPE. All rights reserved.)

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