ISPE -Model Pharma 4.0 -Community of Practice (CoP)
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™.
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.
- Pharma 4.0™ extends/describes the Industry 4.0 Operating Model for medicinal products
- In difference to common Industry 4.0 approaches, Pharma 4.0™ embeds health regulations best practices.
- Pharma 4.0™ breaks silos in organizations by building bridges between industry, regulators and healthcare and all other stakeholders.
- For the next Generation Medicinal Products, Pharma 4.0™ is THE enabler and business case.
- For the established products, Pharma 4.0™ offers new business cases
- Investment calculations for Pharma 4.0™ require innovative approaches for business case calculations.
- Prerequisite for Pharma 4.0™ is an established PQS and controlled processes & products.
- Pharma 4.0™ is not an IT Project.
- The Pharma 4.0™ Operating Model incorporates next to IT also the organizational, cultural, processes & resources aspects.
- 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.
- Pharma 4.0™ is not a must, but a competitive advantage. Missing Pharma 4.0™ might be a business risk.
- When moving from blockbusters to niche products and personalized medicines, Pharma 4.0™ offers new ways to look at business cases.
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.
- Holistic Digital Enablement
- How to provide holistic digital solutions to enable consistent, predictable, mature implementation of Pharma 4.0
- Leads: Nuha al Hafez, Roche and Yvonne Duckworth, CRB
- Process Maps and Critical Thinking
- How to develop process and data mapping to virtual models
- Leads: Volker Roeder, Arcondis and Emmie Heeren
- Plug and Produce
- Enable the transformation from centralized systems to modular, distributed, autonomous manufacturing services
- Leads: Wolfgang Winter, Agilent and Josef Trapl, Memo3 GmbH
- Memo3 GmbHValidation 4.0
- The new paradigm of a less complex validation model
- Leads: Michelle Vuolo, Tulip and David Margetts, Factory Talk
- Management Communication Strategy
- The Pharma 4.0™ elevator pitch for management
- Leads: Teresa Minero, LifeBee and Davide Smaldone, Kenvue
- Continuous Process Verification & Process Automation
- The way to parametric release
- Leads: Alicia Tébar, QBD Consulting and Miquel Romero, Almirall
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.