Pharma 4.0™

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

Mission Statement

The aim is to provide practical guidance, embedding regulatory best practices, to accelerate Pharma 4.0™ transformations. The objective is to enable organizations involved in the pharmaceutical product lifecycle to leverage the full potential of digitalization to provide faster therapeutic innovations and improved production processes 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, definitions, and interpretation, with global pharmaceutical regulations.

While Industry 4.0 has been called a new industrial revolution, Pharma 4.0™ implementation will more likely resemble an evolution in which digitalization and automation meet very complex product portfolios and 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 life cycle. It is also important to develop business cases to showcase which Industry 4.0 automation and digitalization technologies can be applied to the pharmaceutical industry and what implications are faced due to the increasingly complex regulatory challenges in the pharmaceutical and biotechnology industries.

Digitalization, an important component of Pharma 4.0™, will connect everything, creating new levels of transparency and adaptivity for a “smart” plant floor. This will enable faster decision-making, and provide in-line and on-time control over business, operations, quality, and regulatory compliance. Notably, this new connectedness will require higher levels of security, since linked systems heighten vulnerability.

Community of Practice

The ISPE Pharma 4.0™ Community of Practice (CoP) is comprised of ISPE Members engaged in implementing Pharma 4.0™ principles in their organizations or simply wanting to learn more about the concepts and network with other members interested in the topic. Membership in the Pharma 4.0™ CoP is open to all ISPE Members. For information on joining, visit the ISPE Communities of Practice page.

ISPE Pharma 4.0 Leadership Team

Steering Committee Leaders

Christian Woelbeling
Executive Industry Advisor
Körber Pharma Software GmbH
Yvonne Duckworth, PE
Fellow - Digital Technology, Associate
Josef Trapl
Head of Innovation in Life Science
Wolfgang Winter
Software Framework R&D Director
Agilent Technologies Deutschland GmbH
Vinzenz Zauner
PhD Candidate
Vienna University of Technology
EL Representative​
Thomas Zimmer, PhD
VP European Operations
ISPE Liaison

Sub-Committee Leaders

Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Davide Smaldone
Global Business Solutions Director
Johnson & Johnson Consumer Europe
Nuha Al-Hafez
Quality Fundamentals Area Lead
Jens Solsbacher
Quality Project Manager
Sanofi-Aventis Deutschland GmbH
Emmie Heeren
Senior Manager Engineering
Kite Pharma
Arend Jan Wassink
Lead Manufacturing & Process Engineer in Digital Manufacturing and Validation
Capgemini Nederland BV
Michelle Vuolo
Head of Quality
Tulip Interfaces
Alicia Tebar
Founder. QbD & GMP Consultant
QbD Pharmaceutical Services SL
Miquel Romero Obón
Quality Assurance Director

From Industry 4.0 to Pharma 4.0™ Operating Model

ISPE’s Pharma 4.0™ CoP Steering Committee and Working Groups have developed an operating model to apply the principles of Industry 4.0 to Pharma 4.0™ which is summarized in the image below.

Pharma 4.0 to Pharma 4.0 Operating Model banner

From Industry 4.0 to Pharma 4.0™ Operating Model Working Groups

  1. Holistic Digital Enablement (combination of Holistic Control Strategy & Impact and Maturity Model Working Groups)
    • How to provide holistic digital solutions to enable consistent, predictable, mature implementation of Pharma 4.0
    • Leads: Nuha al Hafez, Roche, Yvonne Duckworth, CRB and Jens Solsbacher, Sanofi
  2. Process Maps and Critical Thinking
    • How to develop process and data mapping to virtual models
    • Leads: Emmie Heeren, Kite Pharma and Arend Jan Wassink, Capgemini
  3. Plug and Produce
    • How to develop machine learning and automation
    • Leads: Wolfgang Winter, Agilent and Josef Trapl, Takeda
  1. Validation 4.0
    • The new paradigm of a less complex validation model
    • Lead: Michelle Vuolo, Tulip
  2. Management Communication Strategy
    • The Pharma 4.0™ elevator pitch for management
    • Leads: Teresa Minero, LifeBee and David Smaldone, Menarini
  3. Continuous Process Verification & Process Automation
    • The way to parametric release
    • Leads: Alicia Tébar, QBD Consulting and Miquel Romero, Almirall

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

SIG working group

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.

Pharma 4.0™ Publications

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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


2021 ISPE Pharma 4.0™ and Annex 1 Conference
2022 ISPE Pharma 4.0™ & Annex 1 Conference

7 - 8 December 2022
Vienna, Austria and Virtual