Industry 4.0 in Pharma

Piotr Jurowiec
6 min readJan 16, 2021



Industry 4.0 is a name coined from the fourth industrial revolution brought about by advancements in information technology. These include the Internet of Things (IoT), artificial intelligence (AI), robotics, quantum computing, 3D printing, genetic engineering, and other forms of technology. As a result, Industry 4.0 is the modern combination of manufacturing and industrial platforms as we traditionally know it, with upcoming smart technology. Sometimes it is also referred to as the Smart Factory. Pharma 4.0, as a sub-sector, is a label used to describe Industry 4.0 within the pharmaceutical manufacturing sector.

The primary focus of Industry 4.0 is on the large scale use of manufacturer-to-manufacturer engagements and information systems to increase and improve automation, communication, and monitoring. While not so much information is available on how it can be applied to the problems and issues affecting pharmaceutical manufacturing, there is a wide gap that presents an opportunity in that setting. A considerable aspect is the smart machines that can analyze and diagnose issues without needing human intervention. The changes that have occurred in factories are astronomical. They have become automated and self-monitoring now that the machines have the ability to analyze data and communicate amongst themselves. Therefore, staff members are able to focus on other tasks that result in smoother processes all around the factories.

Industry 4.0 in the Pharma sector

From sensor technology to software to data-based services: Industry 4.0 solutions open up new potential in terms of transparency, quality, security, and efficiency throughout production. In manufacturing today, people talk almost every day about how important developments such as Industry 4.0 and the Internet of Things (IoT) are. But to what extent do these trends apply to the pharmaceutical and biotech industries? What is Pharma 4.0 all about?

In the pharmaceutical industry, particularly complex processes have to be observed and strict regulations implemented during digitization — and it is not easy to do it alone. People, machines, processes, and IT — in the factory of the future, everything and everyone is networked with one another. Intelligent manufacturing is the answer to a market environment that is evolving faster. Products are becoming more individual, manufacturing processes are becoming more complex, and batches are becoming smaller. Manufacturers can meet these challenges by aligning production in such a way that it can be quickly and repeatedly adapted to changing requirements. The basis for digital change lies in the smart use of an almost inexhaustible amount of data.

While Pharma 4.0 has been known as the recent industrial revolution, its usage and implementation will almost certainly look like a development where digitalization and mechanization meet complex item life-cycles and portfolios. Therefore, it is essential to accomplish a recognized understanding of willingness and maturity, beginning with additional digital elements and enablers added to the quality systems. It is likewise critical to creating business cases to feature which Industry 4.0 mechanization and digitalization technologies can be applied to pharma and which suggestions, and implications are being faced because of the growing mind-boggling challenges and difficulties in the biotech and pharma industry.

What is driving to Pharma 4.0?

Past the always existing requirement for regulators of the pharmaceutical industry to stay competitive in a constantly developing market of growing unpredictability and difficulty is the growing push by the regulators for constant monitoring of the product. Before, controllers or regulators used to accept the product quality review annually. However, there is an increasing expectancy that regulators will perform such audits significantly more often than annually. The technology of Pharma 4.0 permits real-time and consistent monitoring of the manufacturing process thus any float away from specified boundaries can be foreseen or identified as well as rectified prior it transforms into a deviation, evading the related associated loss of product and the downtime.

Growing tension on the Research and Development Departments in order to create not just new products quicker than before, yet in addition more customized treatments, is one more reason driving the change to Pharma 4.0.

Efficiency and quality

With Pharma 4.0, the focus is no longer on production according to fixed specifications. Rather, it is about an intelligent and networked system for control of manufacturing processes, simulation, and real-time monitoring. The basis on which all processes are based are data from interconnected systems. With a high-tech system, the manufacturing processes can constantly adapt themselves and offer a high degree of automation. Pharma 4.0 is based on the principles of Quality by Design (QbD) and Process Analytical Technology (PAT), which were introduced in the pharmaceutical and biotech industries more than ten years ago. However, until a few years ago, IT systems were not even able to create and access data for such advanced production control.

Other options

Current automated process control (APC) strategies better oversee the quality when presented in history earlier. As they are responsive in nature, they bear the competency to only mention what is turned out wrong, not what is about to go wrong and within what time span. Whereas Pharma 4.0 is something other than measuring the control only. By expanding measure of checking all through the cycle of production Pharma 4.0 offers a research or analysis that is predictive and a universe of other business-related insights that right now are inaccessible or unavailable on the grounds as they are covered in incomplete, scattered, unstructured, and fragmented information and data.


Big Data and the new ideas around the Industrial Internet of Things (IIoT) have changed the face of many industries besides pharma, namely transport and logistics, manufacturing and production, aviation, oil and gas industry, and many other sectors. There are already applicable concepts such as the 5G connection in the near future, which is aimed at pushing the limits of efficiency to unbelievable limits. With the aim of higher productivity, better quality goods and services, and reduction of costs in Pharma 4.0, every stakeholder is focused on getting on board on every technological release that achieves this. Industry 4.0 is termed as one of the most valuable business ideas of our time.

While Pharma 4.0 operations imply that there are fewer staff members needed on the production line, there are still necessary jobs, such as data scientists. They would have to be adequately skilled, meaning learning and training institutions have to step up the curriculum in order to supply the task force. Also, in order to fully realize the benefits of Pharma 4.0, companies have to mitigate security risks, most importantly, data and information systems security. This means that they will have to invest in properly skilled security staff, leading to a shift in the security personnel too. This job market is still growing, with positions requiring technical knowledge of proprietary systems, big data, open-source ‘R,’ and other related programs.

Smart industrial facilities, which will be at the core of Industry 4.0, will accept data and communication technology for a development in the supply chain, production line, and pharma industry that brings a lot more significant level of both digitization and automation. It means that the machines will utilize self-optimization, self-design, and even artificial intelligence to get done with the complex tasks to convey better quality products or services.



Piotr Jurowiec

Business adviser and senior manager fascinated by how new technologies, like blockchain and AI, revolutionize the economy and create new business models.