March/April 2017
Volume 37, Number 2

     

    IN THIS ISSUE

    Cover: Compliance Challenges for a Global Industry
    Amid the great opportunities that flow from extending their networks of facilities around the globe, pharmaceutical manufacturers are facing compliance challenges in emerging markets—especially culturally distinct ideas about safety, risk, and quality.  

    Feature: The Growing Influence of PIC/S in Asia Pacific
    The Asia Pacific region contains 60% of the world’s population and is the fastest growing region in the world. Of the 24 countries in the region, 19 are being influenced in some way by PIC/S in their regulation of medicine manufacturers.

    Special Report: Sustainability
    This issue’s special report explores sustainability in the life sciences industry, cleanliness classifications for life science facilities, and the origins of 90 fpm as the standard for cleanroom airflow.

    TABLE OF CONTENTS

    Guest Editorial

    Message from the Chair

    A YP State of Mind

    COVER STORY

    Compliance Challenges for a Global Industry
    Pharmaceutical manufacturing requires a global approach to compliance as companies look for competitive advantages in emerging markets. Three ISPE experts share their thoughts.

    PEOPLE + EVENTS

    • ISPE 2016 Europe GAMP®/Data Integrity Regional Conference
    • East to East: Japan Affiliate on the Road in the United States
    • 2017 ISPE Training
    • New Guidance Document Available
    • Meet Young Professional Takenori Sumi
    • Warning: Graphic Content
    • Meet Your Board
    • CFDI Invites ISPE Expert to Participate in Training Program for National GMP Inspectors

    CAREER Q&A

    Career Pivot: Four Steps for a Successful Transition
    David G. Smith, Principle Recruiting Partner, Biogen

    FEATURES

    The Growing Influence of PIC/S in Asia Pacific
    Robert Tribe ISPE Asia Pacific Regulatory Affairs Advisor

    SPECIAL REPORT: SUSTAINABILITY

    Sustainability and the Life Sciences Industry
    Rob Bowen discusses history and breadth of sustainability, the impetus behind ISPE’s Sustainability Handbook, and why it is both an important document and an essential topic.

    Understanding Cleanliness Classifications for Life Science Facilities
    Norman Goldschmidt and Gordon Farquharson discuss the differences within modern classification systems and review space classification before harmonization efforts led to the current systems.

    Why Is 90 fpm Considered the Standard for Cleanroom Airflow?
    David Brande, Dan Milholland, and Nick Haycocks explore the science and the legends behind this enduring standard.

    TECHNICAL ARTICLES

    Cleaning Validation Considerations for Automated Washing Systems
    Paul Lopolito, Olivier Van Houtte, and Marcel Dion

    EU Clinical Trials Regulation: The Application Process
    Juliette Kirk

    EU Clinical Trial Regulation: Annex VI Period of Use Labeling Requirements
    Charles Gentile and Martin Waldherr

    Computers and Data Integrity in Drug Manufacturing: US and EU Regulations 1978–2016
    Yoel Bergman

    Achieving and Maintaining GAMP® 5 Compliance: A Risk-Based Approach to Software Development and Verification
    Diana Bagnini, Barbara De Franceschi, and Margherita Forciniti

    POSITION STATEMENT

    Where Will New Antibiotics Come From?


    NOTE: Pharmaceutical Engineering articles are not to be posted on any website, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2016 ISPE. All rights reserved.)

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