March/April 2017

Volume 37, Number 2



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.


Guest Editorial

Message from the Chair

A YP State of Mind


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.


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


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


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.


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


Where Will New Antibiotics Come From?

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