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Pharma 4.0


Pharma 4.0 is a term used to describe the integration of advanced technologies and knowledge-based processes in the pharmaceutical industry. It aims to use data and technology to streamline the pharmaceutical manufacturing process. Pharma 4.0 offers a digital framework for the integration of digital industrial technologies in the context of pharmaceutical manufacturing. It expands on the ideas of Industry 4.0, the fourth industrial revolution characterized by the development of digital technologies and data. Pharma 4.0 integrates cutting-edge technologies including artificial intelligence (AI), big data analytics, the Internet of Things (IoT), robotics, and cloud computing into pharmaceutical manufacturing. The goal of Pharma 4.0 is to develop a more productive, economical, and patient-friendly pharmaceutical industry using these technologies.



The concept of Pharma 4.0 emerged from the wider Industry 4.0 movement, which began in 2011 in Germany. Industry 4.0 refers to the fourth industrial revolution, which involves the integration of advanced technologies and robotics into production processes. The term Pharma 4.0 first appeared in 2011. In 2017, a group of German researchers and industry experts published a white paper entitled "Pharma 4.0: A Roadmap for Digital Pharmaceutical Manufacturing". The term has been trademarked by the International Society for Pharmaceutical Engineers (ISPE) to harmonize targeting components and enablers. It provides the best practices to accelerate the digital maturation of the pharmaceutical industry. However, the adoption of Pharma 4.0 is still in its early stages and there are many challenges to be overcome, such as data protection issues and regulatory hurdles.


Steps to reach Pharma 4.0

One of the enablers of the Pharma 4.0 operating model is digital maturity. There are six stages in digital maturity. Following these steps will help companies transition to Pharma 4.0.


Step 1: Computerization 

The first level of maturity is the automation of simple manual processes with the introduction of digital technology. The goal is to find repetitive tasks that would be better performed by the computers that form the basis of the digital infrastructure.


Step 2: Connectivity 

In the second stage of Pharma 4.0 maturity, the equipment and devices for drug production are connected to the network. It enables data collection and communication between devices. It also creates a basis for connecting IT infrastructure, business and production.


Step 3: Visibility

At this point, you will see significant progress in your drug production. A connected ecosystem of people, machines and processes creates meaningful digital output that enables intelligent and informed decisions in real-time.


Step 4: Transparency

As more data is collected, Pharma 4.0 enables a new type of transparency never before seen in manufacturing. Everyone in the supply chain has access to the same data, enabling better communication and collaboration. These advanced analytics help uncover opportunities for improvement that were previously anonymous and invisible.


Step 5: Predictability

Detailed production data allows manufacturers to solve problems before they happen. The predictability and precaution lead to less downtime, fewer recalls, and better quality.


Step 6: Adaptability

In the final stage of maturity, Pharma 4.0 manufacturing processes are adjusted in real-time. This is also possible through continuous data collection and the use of advanced analytics. In addition, the systems automate themselves to prevent problems and they in turn initiate the corresponding actions without human intervention. This results in a leaner, more flexible, and more responsive pharmaceutical manufacturing organization.


Infographic that shows the steps to reach Pharma 4.0 | Scilife


Practical Applications of Pharma 4.0

1. Electronic Logbooks 

Electronic logbooks automatically document critical production data, such as streamlining a manual process, while improving data integrity. These logs can aggregate and integrate information about machines and users, increasing process visibility. Electronic logbooks ensure that the information is identifiable, legible, current, original, and accurate (ALCOA).


2. Line Clearance 

Many paper-based line-cleaning processes are complex and time-consuming exchanges. Digital line clearance applications can facilitate line transfer. IoT-enabled digital work instructions guide users through SOP processes, increasing efficiency and ensuring work is done correctly and automatically validated. 


3. Electronic Batch Records

Batch data reviews require merging and verifying large amounts of production data and process documentation.  Pharma 4.0 tools allow manufacturers to make data collection and validation a continuous and seamless part of the manufacturing process. Information about production processes is collected automatically as users and machines work, and all information is, therefore, targetable, legible, up-to-date, original, and accurate.


4. Process Visibility

Process visibility is one of the biggest obstacles to improving pharmaceutical manufacturing processes. IoT devices and human-centric manufacturing applications enable manufacturers to break down complex processes into sub-steps and create a detailed picture of worker performance. The applications allow engineers to monitor the performance of individual users at each stage and identify situations where training may be necessary.


5. Training for Regulated Environment

Manufacturing apps allow manufacturers to design drug-specific training programs to quickly bring employees up to speed. Engineers can use targeted modules to break multi-step processes into sub-segments and embed media such as videos and images to help deliver information to different types of learners. Manufacturers can even simulate processes by running training applications in a production environment using workspaces.



The pharmaceutical industry is developing rapidly. The promise of Pharma 4.0 lies in its ability to unlock new opportunities for productivity and quality, and to make compliance a seamless part of the manufacturing process. Manufacturers who take the necessary steps to embrace the digital future now benefit from seamless compliance, but it doesn't have to stop there. By implementing a Pharma 4.0 strategy, you can increase relationships, efficiency, and flexibility.

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