May / June 2017

What is "Industry 4.0" & Are We Ready for It?

Michael A. Arnold, RPh

“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.”1

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.

We continually strive for excellence in an ever-changing world.

With the “fourth major upheaval in manufacturing”2 hovering 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 devices.

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.