ISPE Europe Pharma 4.0™ Conference: A First-Person Report

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 Interest Group (SIG) at the at Villa Quaranta Hotel, the event featured high-profile speakers from ISPE working groups as well as innovation leaders from pharmaceutical companies, contract manufacturing organizations, equipment vendors, consulting firms, and academia. Topics included end-to-end integration, data integrity and analytics, automation, and the workforce of the future.

It was a conference of firsts: the first time ISPE brought the transformative concept of Industry 4.0 in the highly regulated world of pharmaceutical operations to a European audience, the first time ISPE held an affiliate-supported conference in Italy, and the first time an ISPE Europe conference included content developed by Young Professionals (YPs).

While Pharma 4.0™ has been called a new industrial revolution, its implementation will more likely resemble an evolution in which digitization and automation meet a very complex product portfolio with long life cycles. So it is important to achieve a common understanding of readiness and maturity, starting with enablers and components defined in ICH Q10: Pharmaceutical Quality System. It is also important to develop business cases to be certain the right products are identified, such as full automation.

Digitization, an important component of Pharma 4.0™, will connect everything, creating new levels of transparency and speed. This will enable faster decision-making, and provide in-line and in-time control over business, operations, and quality. Of course, digitization will also require higher levels of security, since connected systems heighten vulnerability.

The Pharma 4.0™ SIG is working on pharma-specific maturity models, as well as those already defined in other industries, via its five subgroups:

1. Holistic manufacturing control strategy based on ICH Q 10: Pharma 4.0™ road map
2. Pharma-specific impact and maturity model
3. Process mapping and data integrity by design
4. Automation and continuous process verification
5. Plug and play automation

To help participants understand these concepts more thoroughly, a group of Young Professionals developed and presented a role-playing workshop. Using a series of virtual businesses, organizers asked the audience to determine each one’s Pharma 4.0™ readiness factor and identify what was needed from each segment of the business to achieve it. (See YP article.)

Attendees agreed that two factors were required for successful implementation: First, management must consider Pharma 4.0™ a strategic value and create a corporate culture to nurture its growth. Second, management must decide what “Workforce 4.0” might look like.

ISPE is already working on this topic; you’ll read about it in future issues of Pharmaceutical Engineering. ISPE is also helping companies and universities define skillsets and job profiles for future employees.

ISPE thanks the Italy Affiliate for its tremendous support in organizing the conference.