The advent of internet has fundamentally changed the course of action of almost every industry. Even though internet has been around for a while, it wasn’t until the emergence of Industry 4.0 that the digital transformation started helping the industries to evolve. While industry 4.0 was expected to address the increased need of personalized products with the help of Internet of Things (IoT) to increase the productivity, aligning with the same, Pharma 4.0 is set to revolutionize the digital transformation in pharmaceutical industry and is a result of increased demand of personalized products (in this case personalized drugs) and thus the increased pressure on R&D for the production of new drugs at a faster pace.
Pharma 4.0 emphasizes on building a single virtual network that connects human, data and machines. It gives a vision to improve quality, productivity and lead times through interconnectivity and automation by gathering real-time data with the help of Internet of Things (IoT) and big data analytics. It provides real-time monitoring of manufacturing process to predict any error or glitch that may occur in the near future, so that necessary measures can be taken to fix it.
How Does It Affect Manufacturing?
Automation of processes helps manufacturers to leverage big data and analytics allowing them to make real-time decisions. Looking at the past trends of manufacturing, it seems that the technological transformation is much needed for pharma manufacturing as they have been facing challenges such as:
- Shift from “one drug that fits all” to personalized therapies
- Complex supply chains due to outsourcing activities which results in high cost of drugs
- Rise of counterfeit drugs
Also, in manufacturing, Pharma 4.0 is a step towards transformation from batch process to continuous process. The batch wise manufacturing process, which has been used for over 50 years, has proven to be lengthy and time consuming. During the course of manufacturing, there are many hold times to evaluate the drug substances which may increase the facility costs and at times may even lead to storage or shipping charges. Every year, the pharmaceuticals industry loses almost USD 50 billion due to the inefficiency of batch processing.
To overcome this, the health authorities are taking definitive measures for promoting connected, flexible, smart and precise continuous manufacturing process. In continuous process, manufacturers don’t need to stop in-between the process, from start to end, for any evaluation. The materials are supplied through an assembly line of fully integrated components. This means, there is no shut down of equipment, no chance of human error and no down time.
For example, in 2016, FDA released a blog entry encouraging manufacturers to switch to continuous process. Many companies have adopted this change in order to catch up with Pharma 4.0. A leading manufacturer of the cystic fibrosis drug has been using the continuous manufacturing process since July 2015. Apart from this, many other leading drug manufacturers are incorporating continuous process in their plants to achieve maximum productivity. Meeting the requirements of Good Manufacturing Practices in the age of Pharma 4.0 can be a challenge.
A Regulatory Compliance Service provider can assist you with compliance audit services for your product. This shift is a huge advantage for the industry as it caters to the need of personalized medicinal products by allowing manufacturers to produce in small amount rather than bulk batches.
Pharma 4.0, with the help of integrated systems and software, is expected to provide tools and methods to the industry that will help in enabling smart manufacturing. It will help manufacturers bridge the gap between manufacturing and automation with technologies such as AI, machine learning, big data, cloud computing etc.
For example, machine learning can help manufacturers to keep up with the pace of transformation by adjusting manufacturing lines and production scheduling. The manufacturing plants which are set up as per Pharma 4.0, will have sensors fitted in each and every component of the manufacturing process. These components can report their own conditions with the help of the sensors and can even predict any failure which is possible in the near future. Imagine the amount of money which can be saved with this!
Quality and Compliance
With the Pharma 4.0, the virtual value chain of quality will solely rely on real-time data exchange. This will be one of the biggest shifts through 4.0. Organizations will rely heavily on electronic submission experts for publishing and submissions. For better quality decisions and continuous improvement, companies are now turning to cloud-based systems which can provide better visibility with the help of predictive analysis. One example of such development in life sciences is managing GxP-critical information. The GxP related data is stored in electronic format which will be located in cloud in a GxP regulated environment for safety and efficiency. Storing the data in cloud gives manufacturers the control over the access of data. Managing and documenting organization-wide data can be a difficult task, but companies can always choose to automate the documentation with help of a Regulatory software solution provider.
Pharma 4.0 provides bunch of technologies which can change the way we look at the functions of an organization. For e.g., big data can help companies to build digital twins which can help to mine better insights from the collected data. To get ahead in the competition, companies need to acquire even deeper knowledge about the data that is floating all across the organization and how it should be connected with the internet of things for the better integration.
To conclude, Pharma 4.0 is a well thought initiative which will help companies to maximize productivity and gain advantage. While many companies have started adapting to this trend, remaining are yet to realize its true value and potential. To keep pace with the new industry standards start aligning your data in a compliant way, which can help your company get ahead of the competition. Consult a Regulatory expert. Stay informed to stay compliant.