Gone are the good old blockbuster days. The pharmaceutical industry is on the cusp of a new age – with the need for personalised therapy, more complex production processes, smaller batch sizes and rising manufacturing costs. It is necessary to continuously adapt to the rapidly changing environment using novel technology and improve operational efficiency and flexibility. And to achieve this, intelligent manufacturing seems to be a definite answer.
Pharma 4.0, based on the concept of Industry 4.0, comprises an amalgamation of four principal technologies that are set to revolutionise manufacturing – the big data, computational power and connectivity; the emergence of analytics and business-intelligence capabilities; new forms of human-machine interaction such as touch interfaces and augmented-reality systems; and improvements in transferring digital instructions to the physical world, such as advanced robotics and 3-D printing.1
Pharma 4.0 is intended to make a leap from a reactive framework to a more predictive framework based upon analytics that can allow to anticipate and address potential challenges across the entire drug development life cycle. While data has been collected over many decades for regulatory compliance, it is only recently that an opportunity to use it to make more informed business decisions has been identified. It is crucial to understand here that Pharma 4.0 is not just the application of new technology. There is no Pharma 4.0 platform or instrument that offers a plug and play solution for interoperability and data exchange. The basis for the digital transformation essentially lies in the smart use of the boundless amounts of available data.
Executed correctly, incorporating the digital capabilities and connectivity of Pharma 4.0 into operations can offer a wide range of benefits. For eg., the manufacturing equipment can be monitored more closely, allowing for predictive maintenance before a breakdown can interrupt the production timeline. A deeper level of transparency can offer greater visibility into the functionality of a facility and processes to help identify not only manufacturing inefficiencies but also problems that may otherwise lead to batch failures. Other advantages from real-time monitoring and advanced process controls include facilitating raw material selection and reducing process variations. With the implementation of a holistic approach, it will be possible to eliminate paper-based processes and data silos with better communication across the lifecycle of drugs. This can help the industry work with greater improved agility, connectivity, and productivity, even in highly regulated facilities. The result will be improved quality, efficiency, and communication.
The use of digitalisation in pharma manufacturing has ushered in newer possibilities for improving quality and efficiency than ever before and ensures compliance as an automatic, seamless part of the quality process. A company must define the business opportunities it can generate by implementing Pharma 4.0 principles holistically (through the application of various elements like product and production process monitoring plans and controls) and accordingly initiate a cultural change from the top-down. This approach will bring cohesiveness and collaboration to an otherwise tough transition.
Pharma 4.0 promises a new era in manufacturing that will help bring about seamless integration in the system, ultimately ensuring high product quality with better patient outcomes. The goal of digitalisation is to help organisations achieve business goals by operating faster, reducing costs, and being more competitive and agile. It’s a big leap! Pharma experts estimate that with smart connected factories, it is possible to generate total savings of 20% or more while improving quality and ensuring reliable deliveries. Specifically, they forecast a 17% reduction of costs related to poor quality, a 15% decline in the cost of converting raw materials into drugs and a 14% increase in delivery reliability. 2