Industry 4.0: What Is Pharma 4.0?

What Is Pharma 4.0?

In its most simplified form, Pharma 4.0 is the updating of the pharmaceutical industry to incorporate advanced digital elements and enablers into the current Pharmaceutical Quality System (ICH Q10). This will enable greater opportunities for process improvements throughout the life-cycle of pharmaceutical products. There'll be a greater degree of connectivity and transparency, which will provide closer control over operations and quality, and allow faster decision-making. On the downside, upgrading to Pharma 4.0 will demand higher levels of security, owing to the increased vulnerability of interconnected automated systems.

Due to the nature of their products, and their capacity to impact on human life, the biotech and pharmaceutical industries are subject to much more stringent regulatory challenges than other industrial sectors. These become increasingly complex in the 4.0 environment, and it's essential for the industry to determine carefully which digitalisation and automation technologies they can apply. Data integrity, documentation and process validation are all rigorously regulated, so that the opportunities for improvement can frequently be outweighed by the necessity for compliance. Adoption of new techniques is therefore relatively slower than in other industries.

What Is Pharma 4.0 In The Broader Spectrum?

As a manufacturing paradigm on the lines of Industry 4.0, Pharma 4.0 will allow manufacturers to alter and iterate their operations and to connect their workers with their resources. This will ultimately produce better patient outcomes, with a better quality product. The model can be introduced wholesale as a new enterprise, or in stages aimed at achieving gradual digital maturity. This begins with elementary computerisation and works its way up towards self-regulating, intelligent automated facilities.

The simplest step on the road to Pharma 4.0 is the replacement of elementary manual processes with basic automation and digital technology. This will help manufacturers to decrease process variability, and improve consistency in product quality. They can simplify complex processes such as machine changeovers or line clearance, and improve their data integrity. Repetitive tasks which can be performed better by computers form the groundwork for creating a digital infrastructure, which is then expanded by increasing IT connectivity.

Once the Internet of Things (IoT) becomes integrated with manufacturing and its related business functions, Pharma 4.0 enters the world of the Industrial Internet of Things (IIoT) and the whole world of interconnected functionality. Adopting the IIoT will offer manufacturers substantial improvements in processes and productivity. The software connecting machines to people and processes will also provide greater transparency and a significant digital production record. This big data can be analysed to offer insights into potential improvements, and to help make data-driven decisions in real time.

Pharma 4.0 is working towards integrated solutions that will provide manufacturers with a faster and more flexible way to plan improvements. These are intended to work within the wider scope of manufacturing execution systems and quality management. Alongside fast configuration and deployment, data collection runs automatically to provide manufacturers with the more holistic production picture that Pharma 4.0 requires to progress. Paper processing of records will be replaced by electronic logs. These can store a much greater quantity and scope of information, which can then be expanded to incorporate regulatory and patient health factors for a vastly improved performance.

The greater availability of data and big data analytics offers a higher degree of predictability, so that manufacturers can benefit from predictive maintenance to fix problems before they occur. At the final stage of integrated digitalisation, the automated systems themselves anticipate potential problems and initiate the appropriate remedial action.