Pharma 4.0™

ISPE and its members are developing the roadmap to introduce Industry 4.0, also called the Smart Factory, to the pharmaceutical industry as Pharma 4.0™.

Mission Statement

We provide practical guidance, embedding regulatory best practices, to accelerate Pharma 4.0™ transformations. Our objective is to enable organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of patients.

ISPE Pharma 4.0 Initiative Logo

Implementing new industry 4.0-based manufacturing concepts in Pharma 4.0™ requires alignment of expectations, interpretation, and definitions with the pharmaceutical regulations.

While Pharma 4.0™ has been called a new industrial revolution, its implementation will more likely resemble an evolution in which digitalization and automation meet very complex product portfolios and life-cycles. It is therefore important to achieve an accepted understanding of readiness and maturity, starting with additional digital enablers and elements added to the ICH Q10: The Pharmaceutical Quality System along the product lifecycle. It is also important to develop business cases to showcase which industry 4.0 automation and digitalization technologies can be applied to pharma and which implications we are facing due to the increasingly complex regulatory challenges in the pharma and biotech industry.

Digitalization, an important component of Pharma 4.0™, will connect everything, creating new levels of transparency and adaptivity for a digitalized plant floor. This will enable faster decision-making, and provide in-line and in-time control over business, operations, and quality. It will also require higher levels of security, since connected systems heighten vulnerability. Shape

The 12 Theses for Pharma 4.0™

  1. Pharma 4.0™ extends/describes the Industry 4.0 Operating Model for medicinal products
  2. In difference to common Industry 4.0 approaches, Pharma 4.0™ embeds health regulations best practices.
  3. Pharma 4.0™ breaks silos in organizations by building bridges between industry, regulators and healthcare and all other stakeholders.
  4. For the next Generation Medicinal Products, Pharma 4.0™ is THE enabler and business case.
  5. For the established products, Pharma 4.0™ offers new business cases
  6. Investment calculations for Pharma 4.0™ require innovative approaches for business case calculations.
  7. Prerequisite for Pharma 4.0™ is an established PQS and controlled processes & products.
  8. Pharma 4.0™ is not an IT Project.
  9. The Pharma 4.0™ Operating Model incorporates next to IT also the organizational, cultural, processes & resources aspects.
  10. The Pharma 4.0™ Maturity Model allows aligning the organizations operating model for innovative and established industries, suppliers and contractors to an appropriate desired state.
  11. Pharma 4.0™ is not a must, but a competitive advantage. Missing Pharma 4.0™ might be a business risk.
  12. When moving from blockbusters to niche products and personalized medicines, Pharma 4.0™ offers new ways to look at business cases.

Special Interest Group

ISPE’s Pharma 4.0™ Special Interest Group (SIG) has developed an operating model to apply the principles of Industry 4.0 to Pharma 4.0™ which is shown in the image below.

From Industry 4.0 to Pharma 4.0™ Operating Model

Pharma 4.0 to Pharma 4.0 Operating Model banner

Working Groups

  1. Holistic Control Strategy
    • How to bridge from ICH Q 8, Q 10 and Q 12 to Pharma 4.0
    • Lead: Nuha al Hafez, Merck KGA & Lothar Hartmann, Phact GmbH
  2. Impact and Maturity Models
    • How to develop a pharma-specific industry 4.0 model based on ACATECH
    • Lead: Manuela Gottschall, Roche, Jens Solbacher, Sanofi & Thomas Lee Johnson, Agile Immersive
  3. Process Maps and Critical Thinking
    • How to develop process and data mapping to digital twins
    • Emmie Heeren, Propharma Group & Michelle Vuolo, Tulip
  4. Plug and Produce
    • How to develop machine learning and automation
    • Lead: Wolfgang Winter, Agilent & Josef Trapl, Takeda
  1. Validation 4.0
    • The new paradigm of a less complex validation model
    • Lead: Michelle Vuolo, Tulip & Tony Margetts, Factorytalk
  2. Management Communication Strategy
    • The elevator pitch for management
    • Lead: Teresa Minero, LifeBee & David Smaldone, Menarini
  3. Continuous Process Verification & Process Automation
    • The way to parametric release
    • Lead: Alicia Tébar, QBD Consulting & Miquel Romero, Almirall
  4. Connected Health
    • Linking Product quality to Patient outcome
    • Lead: Nuha Al-Hafez, Merck KGaA & Rebecca Stanbrook, Novartis

Bridging the ISPE Pharma 4.0™ Operating Model with the Sig Working Groups

SIG working group

Pharma 4.0™ Publications

View More Publications
Must be an ISPE member to view locked content.

Podcast: Pharma 4.0™

Listen in as Barbara Peck, ISPE, and Christian Wölbeling, Senior Director Global Accounts, Werum IT Solutions, discuss the history of Pharma 4.0™, what it is, and how it can benefit your organization.

Developed in 2017, Pharma 4.0™ will help pharmaceutical companies create a fully automated environment that considers data integrity from the beginning of the design period. Christian also reflects on the future of the new digital revolution and explains how you can get involved now.

Listen to Podcast


2019 ISPE Europe Annual Conference

More than 800 attendees met in Dublin, Ireland, on 1–4 April for the 2019 ISPE Europe Annual Conference—a new record attendance for this conference! Participants at ISPE’s sixth Europe conference learned about how manufacturers, key suppliers, functional peer groups, and regulators expect the pharmaceutical industry to be affected by digitization, new products, changing portfolios, disruptive technologies, and other factors.

2019 ISPE Europe Pharma 4.0 Conference

2018 ISPE Europe Annual Conference

The 2018 ISPE Europe Annual Conference in Rome, Italy, attracted over 600 attendees, with Pharma 4.0™ one of the hot topics discussed during the conference. Read more about the event on our iSPEAK blog.

At the 2018 ISPE US Annual Conference in Philadelphia, PA, 2 Sessions were dedicated to showcase the Pharma 4.0™ Holistic Control Strategy Concept and the Pharma 4.0™ Plug & Produce Initiative. And further conferences like the ISPE 2019 Europe Annual Conference will serve its members with a full 2 day Pharma 4.0™ track, having also the FDA speaking to Pharma 4.0™.

You can also read a more in-depth article in our July/August issue of Pharmaceutical Engineering magazine.

ISPE is leading the way with the migration to Pharma 4.0™ and will continue to do so through its conferences and publications.


2017 ISPE Europe Pharma 4.0™ Conference

In addition to supporting a very active special interest group, ISPE has spearheaded the first conference devoted to Pharma 4.0™, 2017 ISPE Europe Pharma 4.0™ Conference, which took place 23-24 November in Verona, Italy. At this event over 230 participants from 19 countries gathered to discuss topics that included end-to-end integration, data integrity and analytics, automation, and the workforce of the future.

To help participants understand the concepts put forward by the SIG, a group of Young Professionals developed and presented a role-playing workshop. Using a series of virtual businesses, the audience had to determine each one’s Pharma 4.0™ readiness factor and identify what was needed from each segment of the business to achieve it. 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.