March / April 2018

March/April 2018

Cover: Reining in Consumption for Sustainable Manufacturing
The word “sustainability” is both overused and abused: We hear about sustainable development in a sustainable economy that uses sustainable packaging for a sustainable future. But it’s an important concept, especially for the pharmaceutical industry as it transitions from manufacturing in stainless steel facilities to single-use technology in much smaller plants. This shift has revolutionized pharmaceutical manufacturing and is producing results that go far beyond the financial.

ISPE 2017 Article of the Year: A Holistic Approach to Production Control

The 2017 Roger F. Sherwood Article of the Year Award winner was originally published in the July-August 2017 issue of this magazine. Written by Prof. Dr. Cristoph Herwig, Christian Wölbeling, and Thomas Zimmer, PhD, it is the first entry in the award’s history in which the judges’ decision was unanimous. The article presents the work of the newly formed ISPE Holistic Production Control Strategy Working Group, which has identified and summarized the need for a redefined control strategy implementation methodology.

Feature: Interview with GSK’s Roger Connor
PE talks with Roger Connor, President, Global Manufacturing Supply, GlaxoSmithKline, whose keynote at ISPE’s 2017 Annual Meeting & Expo made the case for bringing “outsiders” into pharma to jump-start innovative thinking in manufacturing. Jim Breen adds a sidebar about “embracing innovation” and why building facilities of the future is the only way forward.

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Features
Great strides are being made in bioprinting, and the end result could revolutionize pharmaceutical development and testing.
Technical
This article shares a process used to evaluate terminal HEPA filter maintenance programs serving a parenteral manufacturing plant. The evaluation determines whether maintenance history data supports extending preventive maintenance frequency. Terminal HEPA filters in HVAC applications serving Grade...
Insights
In my last column,1 I introduced the Regulatory Steering Committee, which was convened to provide guidance and oversight for ISPE’s regulatory committees and initiatives. This column focuses on the committees and groups that carry out this important work...
Technical
Analytical target profile criteria for judging the quality of results generated by analytical methods are framed in an optimization paradigm by illustrating the ATP criteria as a loss function. In the case where specifications are based on quality arguments and process capability, a...
Features
This article presents the work of the newly formed ISPE Holistic Production Control Strategy Working Group, which has identified and summarized the need for a redefined control strategy implementation methodology.
Insights
This issue highlights a variety of voices and points of view on matters ranging from sustainability to serialization, Pharma 4.0 to viral contamination, and EMA’s new location to game theory. In our cover story, Scott Fotheringham, PhD, interviews...
Features
"When a factory is needed in the future, what could it look like, and how should we think and work differently to build it?" This is a question that Roger Connor, President, Global Manufacturing Supply, GlaxoSmithKline, considers frequently. I had the privilege of meeting him during the ISPE 2017...
Insights
Fellow members, it is my pleasure to provide a short update on some of ISPE's accomplishments, its strategic plan, and ongoing activities.
Features
The word “sustainability” is both overused and abused: We hear about sustainable development in a sustainable economy that uses sustainable packaging for a sustainable future. But it’s an important concept, especially for the pharmaceutical industry as...
Insights
I was inspired to write this editorial after attending the YP and Student Brunch at the 2017 ISPE Annual Meeting & Expo, where Kelly Keen, a member of the ISPE Board of Directors, shared her story. In particular, she emphasized that traveling had been an...
Technical
India is a worldwide leader in drug manufacturing, producing 10% of global pharmaceuticals, with 2016–2017 exports valued at $16.4 billion. 1 Indian generic manufacturers generate 20% of all global exports and more than 80% of antiretroviral drugs in the developing world. 7 India's pharmaceutical...
Insights
Which road map to Industry 4.0 (I4.0) should the pharma industry follow? We explored this question during the YP workshop held during the Verona conference, leveraging “gamification” (a learning technique that incorporates game elements) to determine a...
Features
ISPE has identified facilities of the future (FOF) as a priority in its strategic plan, and is paying particular attention to helping members and corporations understand the skills they will need to advance and maintain a competitive edge. These “musts”...
Insights
From November 23 to 24, over 230 participants from 19 countries gathered in Verona—located in Italy’s high-tech corridor—for a conference focused on the challenges and opportunities of Pharma 4.0. Organized by ISPE Italy and the Pharma 4.0 Special...
Insights
Organizations often augment their workforces to address temporary work requirements. These appointments can range from long-term consulting engagements for complex projects to short-term coverage for employee absences. Over the years, I have spoken with...
Insights
The United Kingdom's (UK) "Brexit" vote to leave the European Union (EU) by March 2019 has created challenges for the European pharmaceutical industry. Among the first important decisions resulting from the impending departure was where to relocate the European Medicines Agency (EMA), currently...
Insights
We all know the saying: There’s no reason to reinvent the wheel. It is likely that someone else has already come up with a workable solution to your particular challenge. We also know the quickest way to conquer challenges is to find that person, learn...