“Industry 4.0” is the networking of information that became possible after several years of disruptive technological innovation. You may have heard related terms such as big data, real-time data, patient data, knowledge management,
data analytics, and the Internet of Things—all of these contribute to real-time decision making in this new technological ecosystem.
As stated by Deloitte University Press, “The term Industry 4.0 encompasses a promise of a new industrial revolution—one that marries advanced manufacturing techniques with the Internet of Things to create
a digital manufacturing enterprise that is not only interconnected, but
communicates, analyzes, and uses information to drive further intelligent action back in the physical world.”
There are several industry initiatives in which ISPE has established a
lead role that either contributes to or leverages the infrastructure within
Industry 4.0: data integrity, drug shortages, quality metrics, quality culture, and facilities of the future, to name just a few.
With the “fourth major upheaval in manufacturing”
overhead, the annual ISPE/PQRI/FDA Quality Manufacturing conference
can’t come too soon. Hot on the heels of the ISPE Conference on Quality
Culture and Quality Metrics and the Data Integrity workshop, the
conference promises to tackle the issues that are top of mind for industry
leaders across the ranks.
So, what do you do in the face of change that seems foreign, unlike
anything you have studied or experienced in your career? You embrace
it, just as you have embraced new ideas, processes, and ways of working.
You do what we (pharmaceutical professionals) do best: You share
knowledge and collaborate. You embrace Industry 4.0.
ISPE members, and indeed all professionals in the pharmaceutical
industry, pride themselves on being innovative and quality focused: We
continually strive for excellence in an ever-changing world. The changes
that are likely to occur as a result of Industry 4.0, therefore, should not come
as a surprise, yet I believe they will be more demanding and influential than
anything we’ve seen before. The pharmaceutical manufacturing landscape
that is beginning to appear suggests a change similar to the one mobile
technology brought about in telecommunications: one that affected not
just industry, but lifestyle as well. The idea of an assistant—like Apple’s Siri
or Amazon’s Alexa—to manage daily activities through a mobile device
was innovative, and to some, perhaps at first, even heretical. Displaying
a name or caller ID on a telephone screen was considered an invasion of
privacy. Once the conversations and debates subsided, however, adoption
of both was global.
In the same way, Industry 4.0 technology offers the promise of personalized medicine, tattoos that deliver drugs, and printed 3-D medical
At ISPE, our staff, members, and volunteers stand ready to offer training and professional insight through our conferences and workshops,
and to help members enhance current skills and learn new ones. Our
guidance documents provide in-depth knowledge that brings together
the expertise of members around the world. The pages of this magazine
will publish member articles about their experiences with quality culture,
quality metrics, and innovative manufacturing opportunities. The annual
FOYA supplement (which accompanies this issue) will showcase the best
our members have to offer in areas of facility integration, process innovation, sustainability, project execution, and equipment innovation. We are
well positioned to support our members as we progress enthusiastically
into Industry 4.0.
On a related note, I hope to see you at the FOYA Banquet on 6 June,
where we will recognize the achievements of five companies that have
earned category awards, and three that have won honorable mentions.
This year’s winners are exceptional by design. Their winning submissions
demonstrated excellence in strategic planning and a clear vision of
success, both of which are essential for excellent execution of a mandate.
I invite you to join us as well at the 2017 Annual Meeting in San Diego,
where we will announce the 2017 FOYA Overall Winner.
Enjoy your summer. ‹›
1. Deloitte University Press. “Industry 4.0.” https://dupress.deloitte.com/dup-us-en/focus/
2. Baur, Cornelius, and Dominik Wee. “Manufacturing’s Next Act,” McKinsey & Company,
June 2015. http://www.mckinsey.com/business-functions/operations/our-insights/
AND ARE WE
READY FOR IT? Mike Arnold, Senior Director at Pfizer, and Chair of ISPE’s
2016-2017 International Board, Member since 1998