Pharma 4.0, an operating model for pharmaceutical factories and supply chains is based on Industry 4.0 capabilities, digital maturity, and data integrity by design. It focuses on technology, integration, workforce and quality control. It is fueled by developments in big data, interconnectivity, collaborative robotics, artificial intelligence, and distributed cloud service-based architectures. Digitalization is enabling the change across the organization and along with the value chain network. With Pharma 4.0, the virtual value chain relies on seamless, real-time data exchange and not on paper filing. Continuous, real-time monitoring of manufacturing processes is possible through Pharma 4.0 thus eradicating any drift away from specified parameters. It enables prediction and rectification before anything turns into a deviation, avoiding the associated down time and loss of product.

PHARMA 4.0 Operating Model (Source: ISPE SIG “Pharma 4.0”)

Pharma-4.0

Pharma 4.0 is aimed at reducing pharmaceutical manufacturing problems by increasing quality and productivity coupled with decreasing risk and waste. Companies such as Johnson & Johnson, Vertex, Glatt, GSK, Lonza and Pfizer has been seamlessly working on the implementation of Pharma 4.0 and has been successful in gaining approvals from regulatory bodies and reap benefits. Considering Pharma 4.0 of strategic value and creating a corporate culture to nurture its growth is of prime importance for companies to succeed with Pharma 4.0 implementation. The cost of fitting out a pharmaceutical manufacturing site according to Pharma 4.0 principles is high, however, the results may quickly offset the cost by increasing the productivity and reduction of downtime and waste. Recently, ViforPharma Group and its partner company Goodly Innovations were awarded the 2018 Pharma 4.0 Award for the innovation of the year in manufacturing execution systems in the pharma industry. ViforPharma was the first company to pilot a dynamic team-based augmented reality system in a pilot project at its site. Drug development is another area where Pharma 4.0 can be implemented. Most of the data in this area is in unstructured form and thus Pharma 4.0 can enable speeding up and the connection of unstructured data.

Predictive Analysis plays a key role in Pharma 4.0 owing to the monitoring capabilities today throughout the production cycle. However, the amount of stored data which is in unstructured, dispersed, incomplete form acts as a barrier. Difficulty in predicting what skills industry will require in coming years to run the analytics is another key factor impacting the Pharma 4.0 adoption. As Pharma 4.0 involves connecting thousands of individual devices such as sensors, actuators and networks, security acts as another concern. Thus investments in skilled security staff will lead to reap the benefits of Pharma 4.0 and mitigate the security risks for the companies.

Pharma 4.0 has given manufacturing intelligence a new meaning and is set to facilitate generational change in manufacturing. It is providing the ability to move from reactive to predictive and from strict to adaptive process control. This is creating “smart” manufacturing and is adding flexibility to the physical processes involved. With the continuous and cautious testing, Pharma 4.0 concept is gaining momentum. FDA has been actively encouraging the pharma industry to catch up with other industries with regards to the adoption of the Industry 4.0. Along with the big pharmaceutical companies, small and medium companies can also reap the benefits of Pharma 4.0 and thereby become advance manufacturers. As data integrity expectations for regulators increase, demand for more flexible manufacturing, personalized medicine, smaller batch sizes and continuous manufacturing grows, pharmaceutical companies needs to focus on climbing the steep part of the adoption curve in order to make digital manufacturing plant a reality.

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