Digitalisation in pharmaceutical manufacturing: the interplay between technology and human expertise
An outlook by Christoph Reinwald, General Manager at Complex Pharmaceuticals.
Digitalisation and Pharma 4.0 are transforming the requirements for modern production structures. Sensors, networked systems, automated processes and digital models are creating new opportunities for the collection and processing of production data.
What matters here is not the use of individual technologies, but their specific contribution to process reliability, product quality and the reliable management of production processes.
In the pharmaceutical industry, machinery and systems provide the technical foundations for quality, security of supply and compliance. However, it is the people who operate, monitor and continuously develop these systems in a skilled, responsible and critical manner who are crucial.
— Christoph Reinwald, General Manager bei Complex Pharmaceuticals
Digitalisation in pharmaceutical manufacturing is therefore not an end in itself. It promotes transparency in processes, the availability of relevant information and the continuous improvement of production processes.
Where digitalisation makes a tangible contribution
In a GxP-regulated environment, the reliable and traceable collection and processing of process data is of paramount importance. Automated data collection and the controlled exchange of data between different systems make it possible to make processes more transparent and reduce manual tasks.
Real-time transparency:
Production data such as running times, downtime and capacity utilisation can be recorded automatically and analysed in real time. This enables potential deviations in trends to be identified at an earlier stage and appropriate measures to be taken.
Traceability:
Digital systems support the end-to-end tracking of material and process data – from delivery through processing and packaging to serialisation. This creates a transparent data foundation across the relevant process steps.
The focus is on three key areas of activity:
- Validation of computer-based systems
- Integration of existing systems and interfaces
- Ensuring data integrity and IT security
Digitalisation at Complex Pharmaceuticals
At Complex Pharmaceuticals, the focus is on the practical benefits of digital technologies. Interconnected systems provide a reliable data foundation for the targeted control, transparent monitoring and continuous improvement of production and packaging processes.
A key aspect here is the flexibility of production structures. Varying batch sizes, packaging formats and process requirements call for systems that can be adapted accordingly whilst adhering to defined quality standards.
Technological development is also changing the demands placed on the teams involved. Employees must be able to understand digital systems, evaluate process data and contextualise the results within their respective specialist fields.
“Technology can be copied quickly. Culture cannot. The way people work together, how decisions are made and how responsibility is taken is actually what sets us apart from the competition.”
— Christoph Reinwald, General Manager at Complex Pharmaceuticals
Technology as part of an integrated production system
The continued digitalisation of pharmaceutical production will increasingly depend on how effectively plant, software, data and existing quality processes can be integrated.
Technology creates additional opportunities for transparency, process control and automation. The expert evaluation of information and its responsible implementation within defined quality standards remain central components of pharmaceutical production.
Digitalisation therefore does not mean shifting responsibility onto systems, but rather the further development of production processes through more readily available and usable information.