May/June 2013
Volume 33, Number 3


    Supply Chain Management

    Establishing and Managing a Vendor Network for Clinical Supply Manufacturing Services
    by Francis Dumont and Sandra Onorato
    This article presents some essential operational and evaluation aspects of the Request for Information/Request for Proposal (RFI/RFP) process when conducted for the purpose of establishing a vendor network for clinical supply manufacturing services.
    Download Article... (,1.Mb)

    Industry Interview

    Pharmaceutical Engineering Interviews
    Roger Nosal, Vice President, Global Chemistry, Manufacturing and Controls (GCMC), Pfizer
    Download Article... (,513.Kb)

    Facilities and Equipment

    An “Eco-Friendly” Assessment of Cleaning Agents in GMP Regulated Facilities
    by Elizabeth Rivera
    This article discusses cleaning agents used in GMP applications and relevant issues in minimizing pollution, reducing waste, managing personnel hazards, and complying with local regulations.
    Download Article... (,355.Kb)

    Facility of the Future: Next Generation Manufacturing Forum Part III: Identifying Facility Requirements Based on Specific Business Drivers and Uncertainties Using the Enabling Technologies
    by Mark Witcher, PhD, Jeff Odum, CPIP, and Michael Zivitz
    This article is the third of a three-part series focused on defining the facility of the future required for manufacturing biopharmaceuticals in the 21st Century.
    Download Article... (,1.Mb)

    Information Systems

    Effective Computerized System Compliance through Leveraging Supplier Effort
    by Members of the ISPE GAMP® Leveraging Supplier Effort Special Interest Group
    This article describes a controls framework that can be used to assess risks and determine a validation strategy that leverages supplier effort appropriately.
    Download Article... (,652.Kb)

    Quality Systems

    Commissioning and Qualification (Verification) in the Pharmaceutical Product Process Lifecycle
    by David Dolgin
    This article discusses the role of Commissioning and Qualification as “Stage 2a” of the Process Validation Lifecycle described in the US FDA’s Guidance on Process Validation. It also explains how the concepts of Quality Risk Management and QbD are incorporated into facility and system verification efforts as detailed by two recently published ISPE Guides.
    Download Article... (,994.Kb)

    Regulatory Compliance

    A Comparison of Process Validation Standards
    by Jeff Boatman
    This article presents a comparison between the Global Harmonization Task Force (GHTF) validation standard and the US Food and Drug Administration’s (FDA’s) process validation guidance.
    Download Article... (,384.Kb)

    Global Regulatory News

    Download Article... (,661.Kb)

    President's Message

    ISPE Members Making an Impact on Industry Issues Worldwide
    ISPE President and CEO Nancy Berg discusses the impact that ISPE’s new direction is making on individual Members, the companies they work for and regulatory and industry relationships around the world.
    Download Article... (,433.Kb)

    Also Inside

    ISPE Update
    - Second ISPE-FDA Event Attracts Top Names, Features Release of Drug Shortage Survey Results
    - ISPE Releases New Guidance for Standardizing Use of Booklet Labels in Global Clinical Trials
    - ISPE Releases New Guidance for Definition and Use of NIMPs in Clinical Trials

    Download Article... (,572.Kb)

    Classified Advertising with Advertiser’s Index

    Download Article... (,303.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 © 2012 ISPE. All rights reserved.)

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