January/February 2009
Volume 29, Number 1

 

    Articles

    Online Total Organic Carbon (TOC) as a Process Analytical Technology for Cleaning Validation Risk Management
    by Keith Bader, John Hyde, Peter Watler, Amber Lane
    This article offers an alternative method to cleaning validation using online total organic carbon analyzers to determine cleaning validation in-situ. Methods are compared with traditional laboratory analysis.
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    Using Visible Residue Limits for Cleaning
    by Richard J. Forsyth
    This article presents the use of visible residue limits. Parameters were defined, their ruggedness determined, and applications described.
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    Industry Interview Series: Senior Staff Members from China’s State Food and Drug Administration (SFDA)
    by Robert P. Best, Robert W. Tribe, Paul N. D'Eramo, Cheryl Siow
    In this interview, senior staff members from China’s State Food and Drug Administration share the latest developments and achievements of China’s activities in drug manufacturing and supervision of drug safety, and ideas for future potential cooperation with ISPE and other international organizations in the industry.
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    Beyond the Bell Curve: A Report on Managing Capital Project Risk
    by Jeff Lukowski, Mark Bridgers
    This report presents the results of the FMI/CMAA Ninth Annual Survey of Owners and provides insight into how companies with ongoing capital construction programs manage risks on projects.
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    Fundamentals of Bacterial Adhesion Applied Toward Infection Prevention: Focus on Two Case Studies
    by Yatao Liu, , Joshua Strauss, Terri A. Camesano, Paola A. Pinzon-Arango
    This article presents a fundamental understanding and practical application of bacterial adhesion, the first step leading to infections. This article specially focuses on two cases, cranberries and urinary tract infections, and implanted biomaterial infections.
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    Considering Outsourcing? Risks and Benefits for FDA-Regulated Firms
    by Mukesh Kumar, PhD, RAC
    This article is being reprinted with permission from the October 2008 issue of Regulatory Focus, the monthly publication of the Regulatory Affairs Professional Society (RAPS).
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    Attachment

    Country Profile: China - Jan/Feb 2009

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    Departments

    ISPE Update

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    Classified Advertising with Advertiser’s Index

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    Online Exclusive Articles

    Global Regulatory News

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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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