Pharma Production 4.0 - The digital future of the pharmaceutical industry

Industry 4.0 is currently one of the most discussed topics in all sectors. It is said of the pharma industry that it has “slept through” the trend toward digitalization. Strictly speaking, however, pharma has not been sleeping, but still needs to clarify many details.

The fourth industrial revolution is supposed to open up a completely new world for manufacturers: machines, materials and products will communicate with one another using sensors and networks and control themselves. Production will become faster, more flexible and more individualized. In the future, plant and machine suppliers will also play a major role – before, during and after the production process. In many cases, they already supply their know-how, the requisite technologies and services during the development and scale-up phases.

Opportunities, doubts and realistic expectations
Pharmaceutical companies appreciate the significance of these possibilities. According to a Bitkom study, 97% of drug manufacturers consider digitalization a great opportunity. Only 3% see the advantages outweighed by the risks arising out of a lack of technological standards or data security deficiencies. So far, however, Industry 4.0 has not achieved a great breakthrough in the pharma sector. One-and-a-half years ago, Handelsblatt, the German business daily, headlined a report “Pharma Sleeps Through Digitalization”. Actually, however, the study by Camelot Management Consultants to which the report referred paints a more differentiated picture. It says that Industry 4.0 is becoming increasingly relevant to pharma companies. However, it will only arrive at the top of the agenda around 2030.

Nevertheless, digitalization is already of greater importance in some business areas: above all, in supply chains and logistics.
Here, according to the study, roughly 60% of the pharma companies surveyed expect digitalization to be highly important by 2020. This figure rises to an anticipated 95% by 2030. When it comes to production, roughly one third assume digitalization will be highly important by 2020, with the number rising to just under two third by 2030.

From dream to reality
On the basis of this survey, Industry 4.0 is establishing itself in the pharma sector slower than, for example, in the automotive industry. Nevertheless, it will rise to the top of the agenda here too and become a decisive factor in future competition. Long-term planning here would not seem too cautious: after all, it concerns sensitive products and fundamental technological changes.
In part, changes of this kind are already taking place today in pharmaceutical production – not yet generally, but in many concrete innovations. If you want to undertake initial steps toward Pharma 4.0, you cannot go wrong with Excellence United IT-based solutions, for example.
The alliance offers modular systems for horizontal and vertical process automation, modern interfaces for integrating manufacturing
execution systems (MES) and enterprise resource planning (ERP) systems, a certified service portal for process optimization and a multipurpose platform for continuous manufacturing.

Quality 4.0 points the way Forward
In a highly regulated environment like drug manufacturing, changes have to be planned especially carefully. Companies are also receiving encouragement from authorities like the Food and Drug Administration (FDA). In its initiatives it is supporting not only the shift to continuous manufacturing, but also the change to a system of highly integrated, paperless documentation. On the path toward a new quality culture, industry experts are increasingly referring to Quality 4.0. The term signifies a form of quality management that defines production and all associated quality data within the new digital environment. This makes the path to Pharma 4.0 clearer and, ultimately, only half as long.