July/August 2013
Volume 33, Number 4


    Information Systems

    Compliant Cloud Computing – Managing the Risks
    by David Stokes
    This article presents pharmaceutical business process owners with an explanation of what cloud computing is, how it differs from traditional Information Technology (IT) outsourcing, and how the specific risks associated with cloud computing’s essential characteristics can be understood, assessed, and mitigated.
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    Has MES Reached Maturity in the Pharmaceutical Industry?
    by Desmond Savage
    This article presents the findings of a study that demonstrates MES is being adopted by the pharmaceutical industry.
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    A Leaner Software System Development Process
    by James E. H. Stafford, PhD
    This article presents new insights into software design, including a more efficient way to implement software without undermining regulatory expectations.
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    Research and Development

    An Introduction to the ISPE IP COP Survey on Patient Experience Related to Investigational Medicinal Products
    by Christine Milligan, PhD, MBA, Esther Sadler-Williams, MSc, MRPharm S, and Karen Gram, MSc (Pharm)
    This article presents a summary of a survey on patient experience related to Investigational Medicinal Products (IMPs) conducted by the ISPE IP COP.
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    Regulatory Compliance

    Good Manufacturing Practices for Halal Pharmaceuticals
    by Kenny Peng, MASc, RAC, PEng and Roziah Hanim Abdul Karim, BS
    This article presents an overview and analysis of a new national standard on halal pharmaceutical products, MS 2424:2012, published by Malaysia, a member of PIC/S.
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    Regulations and Guidelines of Computer Systems in Drug Manufacturing – 25 Years Later
    by Orlando López
    This article presents a regulatory review of the current requirements applicable to computer systems in the manufacturing environment..
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    Global Regulatory News

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    Facilities and Equipment

    Innovative Mixing Technology
    by Gabriela Mikhaiel
    This article discusses fundamental challenges in powder mixing and an innovative mixing technology aimed to improve blending processes.
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    Also Inside

    From The Editor

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    ISPE Update
    Quality by Design in the Biopharmaceutical Industry; The GAMP® Community Celebrates 21 Years; A Special Thank You to ISPE Guidance Document Team Members
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    New Product Highlights and Classified Advertising with Advertiser’s Index

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    President's Message

    Members Are the Strength of ISPE
    by Nancy Berg
    ISPE President and CEO Nancy Berg discusses the importance of active participation in the Society and how it leads to the development of pivotal events, initiatives, and publications that are shaping the industry and strengthening regulatory relationships.
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    Online Exclusives

    The Culture of Quality
    by Randolph Fillmore
    This article summarizes discussions on quality that took place throughout the ISPE Second Annual Conference on Redefining the "C" in CGMP.
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    Quality Risk Management to Deliver Therapeutic Benefit: A Holistic Approach
    by Jaspreet Gill
    This article presents a summary of a presentation on a holistic approach to Quality Risk Management by Jaspreet Gill, Vice President of Global Quality and Compliance at Baxter.
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    GAMP 21 Years Later
    by David Selby
    In this special Online Exclusive GAMP 21st Anniversary commemorative article, founding chair David Selby and other GAMPers give a personal view of the history, the present, and the future of the GAMP COP.
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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 © 2013 ISPE. All rights reserved.)

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