The terms ‘Internet of Things (IoT)’ and ‘Industry 4.0’ reference technology-driven initiatives that have begun to disrupt traditional manufacturing methods, equipment and processes. In this post, we’ll explore the relevance of these terms for the pharmaceutical and biotech industries. We’ll attempt to answer the question of how we can apply them to improve the world of pharmaceutical manufacturing – and bring about Pharma 4.0.
What is Pharma 4.0?
Pharma 4.0 represents a shift away from focusing on producing to a fixed specification. Instead, Pharma 4.0 revolves around a system of real-time monitoring, simulation and control of manufacturing processes. The goal is to enable processes to self-adjust based on data from interconnected systems running throughout the operation. This concept builds on the principles of Quality By Design (QbD) and Process Analytical Technology (PAT) that started over a decade ago in the pharmaceutical and biotech industries. Until recently, however, our systems simply have not been able to produce this data and make it accessible for such advanced control.
Meeting GMP regulations
It is well understood in the pharma industry that we must meet the stringent requirements of GMP regulations through careful control of operations, and testing and control of the software used to produce critical medicines. This helps explain why – although we may be able to dream about a world where a complex and futuristic combination of robotics, automation, embedded internet connected sensors and integrated enterprise software are running our manufacturing – it can be difficult to figure out how to make it a reality. The dramatic disruption seems almost too great to imagine.
The Pharma 4.0 world can only become a reality when we have the necessary base data platforms in place. Integrated tools and devices will function alongside human operators for greater usability and awareness. Machines and equipment will be fitted with sensors that are constantly monitoring every aspect of operation, and as ‘self-aware’ components, be able to report on their own condition, indicating when they are likely to fail. Software will be put into place to enquire into data for self-learning and to highlight, propose and take action to improve current running production. In the best of worlds, Pharma 4.0 will not only improve efficiency, but in addition – by eliminating the need for human/manual intervention – will facilitate higher levels of quality, an objective of particular importance in pharmaceutical manufacturing.
The current reality
Most companies, at least at some level, still rely on paper systems to produce the right product at the right quality and cost. This is problematic, because paper systems often create operational problems related to a lack of timely or accurate information. The current reality for many production and quality managers is that they are forced to work under constant stress to release products, and that they spend a great deal of time fire-fighting issues. They do not have the information needed to decipher the root causes of problems and sufficiently address negative trends and unreliable cycle times. Truth be told, since many companies haven’t even sufficiently achieved Industry 3.0 capabilities, we have to wonder how they can start moving towards Pharma 4.0.
Let’s start the journey
While many companies may have a long way to go, it is imperative that they start the Pharma 4.0 journey. As data integrity expectations for regulators increase, and demand for more flexible manufacturing such as QbD, personalized medicine, smaller batch sizes and continuous manufacturing grows, it seems quite clear that it’s time to move away from recording, managing and extracting information from data that is locked away on paper records.
Though we don’t know how or when we’ll reach our final destination, the initial pilots of modern IT solutions in other industries and sectors show how promising and exciting the Pharma 4.0 journey can be. This is clearly an excellent time to be working in the industry, as the world of pharma becomes more responsive and open to change than ever before.