Pharma 4.0: Is your organization Pharma 4.0 ready?

Pharma 4.0: Is your organization Pharma 4.0 ready?



Lean more about Pharma 4.0 and how Pharma 4.0 technologies enables efficiencies through real-time process optimization and data-driven-decision management within your organization. In this article we will discuss the following topics:

  •  What is Pharma 4.0?
  •  Pharma 4.0 technologies and components.
  •  What are benefits of implementing Pharma 4.0 technologies?
  •  Pharma 4.0 automation and digitalization technologies use cases.
  •  Conclusion.

What is Pharma 4.0?


Pharma 4.0 is an evolution of pharmaceutical manufacturing that implements Industry 4.0 in its production and business processes. Pharma 4.0 is:

  • A framework to enable your organization into digital strategies (digitalization) to provide faster innovations for the benefit of your patients.
  • Combines cyber-physical systems, the Internet of Things (IoT) and the Internet of Systems into a network that are digitally connected with one another.
  • Involves people, data, and physical systems and the creation and implementation of autonomous computerized systems.
  • Using advanced information solutions to create a new business landscape. 

The International Society for Pharmaceutical Engineering (ISPE) and its members are developing the roadmap to introduce Industry 4.0, also called the Smart Factory, at the pharmaceutical industry as Pharma 4.0.

Pharma 4.0™ is a trademark what is developed by the ISPE and its members.

Visit the ISPE website for more information.


Pharma 4.0 technologies and components 

Pharma 4.0 describes the trend towards automation and data exchange in technology and processes within the pharmaceutical industry, including: 

Internet of things (IoT) platforms: 

  • Augmented reality/wearables
  • Smart sensors
  • Mobile devices
  • 3D printing
  • Location detection technologies
  • Cloud-computing
  • Autonomous vehicles
  • On-demand availability of computer systems

Cyber-physical systems (CPS): 

  • Cleaning robots
  • Smart lightning systems
  • Smart heating
  • Insulin pumps
  • Windmills
  • HVAC systems

Smart factories: 

  • Multilevel customer interaction and customer profiling
  • Big data analytics and advanced processes
  • Data visualization
  • Electronic batch records
  • Self-driving vehicles
  • (Collaborative) Robots
  • Energy storing
  • Predictive maintenance
  • Transmission technologies (RFID chip, WLNA, QR codes)

Cognitive computing: 

  • Authentication and fraud detection
  • Speech recognition
  • Face detection
  • Artificial intelligence
  • Self-driving cars
  • Drones
  • Virtual assistants
  • Algorithms
  • Advanced human-machine interfaces
  • Live training / education

What are the benefits of implementing Pharma 4.0 technologies?

Increased productivity & process optimization

  • Faster and more accurate
  • Less wasteful
  • Faster decision making
  • Reduced downtime
  • Integrated supply chain


Increased quality

  • Improved planning
  • Continuous improvement & operational excellence
  • Real-time release
  • Reduction of errors/deviations due to continuous monitoring
  • Greater accuracy will reduce risk of poor-quality products


Smart business strategy

  • Real-time control over business, operations, and quality
  • Creation of new business opportunities
  • Reduce risk
  • Increased profit due to reduced costs of transportation and communication


Simplified compliance

  • Pharma 4.0 technologies (e.g., wearable and biometric technologies) can be used to support data integrity and other regulations

Pharma 4.0 automation and digitalization technologies use cases

Wearable and biometric technology in the pharma industry is moving forward. In the table below we have listed some examples of Pharma 4.0 automation and digitalization technology examples that are already available.




The Pharma 4.0 technologies creates an operation and business environment whereby computerized systems and manufacturing systems are augmented with wireless connectivity, smart sensors to monitor and visualize production and business processes and make autonomous decisions. 


Pharma 4.0 readiness check:

To adopt Pharma 4.0 approaches within your organization there are some important restrictions that need to be addressed. You can use the following questions to determine if your organization is ready for Pharma 4.0:

Leadership & strategy:

  • Is management ready to incorporate Pharma 4.0 in the strategy and corporate culture?

Organization and information technology maturity:

  • What is the current maturity level of the organization?
  • Is the organization flexible and able to react to external changes?
  • What type of quality management system is available to manage and control the quality processes? (e.g., paper based versus electronic systems)
  • Is data integrity by design integrated in the applicable systems and processes?
  • People & culture:
  • Do we have the required resources (knowledge & employees) to implement innovation and change?


How can Rescop help and what is the role within the project ?

  • Computerization; Introduce digital technology to automate simple manual process
  • Connectivity; Expand manufacturing IT infrastructure and lay the foundation to integrate IT, manufacturing and business functions
  • Visibility & Transparency; Connected people, machines and processes and create a substantial digital record of production that can be used to make real-time, data-driven decisions
  • Traceability; Automated trace of all connected information of all connected systems
  • Predictability; Detail production records enable manufacturer to correct problems before they happen
  • Adaptability (the final stage of maturity); Systems anticipates problems and initiate the proper action by them selves

Read more : Pharma 4.0 or contact us!




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