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What is Pharma 4.0 and How Can It Change The Industry? ISPE

Pharma 4.0™

With ever emerging technology the pharma industry is prized to take a giant leap forward. But what exactly is it and how will it shape the future of Pharma?

ISPE and its members are developing a 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


Today ISPE and others offer comprehensive training on Pharma 4.0 and how to implement it into your business. As this seems to be the future roadmap, it would be good for all of us to start familiarizing ourselves with it and figure out how to make it a part of our own companies. With new technology comes new opportunities for jobs and at Westco, we plan on being at the forefront. 

I’d like to thank ISPE for their robust knowledge base and options to learn and and master this new development in the industry. Its’s going to be an interesting time! 

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