July/August 2010
Volume 30, Number 4



    Quality by Design using an Integrated Active Pharmaceutical Ingredient – Drug Product Approach to Development
    by Vince McCurdy, Mary T. am Ende, Frank R. Busch, Jason Mustakis, Peter Rose, and Mark R. Berry
    This case study demonstrates how Quality by Design transcends API synthesis through to the final drug product.
    Download Article... (,5.Mb)

    Virtualization – Compliance and Control
    by Ulrik Hjulmand-Lassen
    This article presents the advantages and risks associated with the use of virtualization techniques in regulated areas and provides a list of quality focus issues to review, as a prerequisite to avoid the most likely pitfalls.
    Download Article... (,1.Mb)

    Process Transfer to Contract Manufacturing Organizations: A Case Study on Process Development Support Past Regulatory Approval
    by Amy Webb, David H. Reifsnyder, and Jean Bender
    This article presents a process transfer case study and the significance of continued project support after the site is licensed.
    Download Article... (,3.Mb)

    Computational Fluid Dynamics as a Tool for Designing Quality into the Pharmaceutical Cleanroom
    by John Gafford, Jesse Roberts, and Joe Sullivan
    This article presents three different case study applications of CFD modeling.
    Download Article... (,4.Mb)

    Industry Forces Driving Standardization of the Turnover Package
    by Roy F. Greenwald and Bill Schaidle
    This article provides an overview of the past and present approaches to formatting of turnover packages for equipment and modular assemblies. It highlights the lack of standardization within the industry and presents an example of an approach that could serve as a starting point for an industry standard.
    Download Article... (,3.Mb)

    Engineering Information Management – Electronic Project Data from Design through Delivery
    by Robert Velén, Dennis Naughton, and Rolf Strömgren
    This case study explores lessons learned in data delivery from a decade of facility projects between Eli Lilly (facility owner) and Pharmadule (contractor), focusing on their latest project in Ireland. Perspectives from both the facility owner and contractor are provided.
    Download Article... (,2.Mb)


    ISPE Update
    - Risk-MaPP Guide to Provide Scientific, Risk-based Approach to Managing Risk of Cross Contamination - New Knowledge Brief - ISPE Participants First to Hear Details of CDER Update on Part 11 - New on ISPE.org: Comprehensive GMP Resources - ISPE Brussels Conference to Focus on Risk-based Control Strategies in Pharmaceutical Industries
    Download Article... (,331.Kb)

    Classified Advertising with Advertiser’s Index

    Download Article... (,147.Kb)

    Online Exclusive Articles

    Global Regulatory News

    Download Article... (,183.Kb)

    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 © 2010 ISPE. All rights reserved.)

     Get the Pharmaceutical Engineering App
    Available for
    Available at the App Store
    Available on Google Play
    Available for Amazon Kindle