What is Pharma 4.0?
July 19, 2022
Everything you need to know about Pharma 4.0
Pharma 4.0 is a new concept that is becoming more important for pharmaceutical and life sciences manufacturing. Although Industry 4.0 is a new concept many people understand, manufacturers are still unclear on what Pharma 4.0 is and how it will impact them. Pharma 4.0 is the application of Industry 4.0 concepts to the pharmaceutical and life sciences industries.
Industry 4.0 is the fourth industrial revolution, a term first used in 2011 by a German government initiative to describe the changes in manufacturing brought about by digital technologies. Pharma 4.0 was introduced in 2017 by ISPE and builds on these concepts and takes a holistic approach to the implementation of digital technologies and a digital mindset within a pharmaceutical enterprise.
The Pharma 4.0 operating model is divided into four discrete areas:
2. Organization and Processes
4. Information Systems
In addition to these four areas, there are two ‘enablers’ that help drive it:
1. Digital Maturity
2. Data Integrity by Design
These are key to establishing a sound digital strategy that will work for a pharmaceutical company’s unique regulatory compliance needs.
Along with the operating model the ISPE Pharma 4.0 special interest group introduced these 12 theses for Pharma 4.0, they can be found here.
Pharma 4.0 and Digital Maturity
As the Pharma 4.0 operating model and the 12 theses makes it clear, Pharma 4.0 takes a holistic approach to the implementation of digital technologies and a digital mindset within a pharmaceutical enterprise.
This leads to the concept of digital maturity, which is in essence a measurement of an organization’s position along a spectrum. It ranges from minimal use of computers and automation all the way to a completely digital autonomous plant that adapts on its own to changing manufacturing conditions.
There are many ways to measure digital maturity, but two common indices are the Industry 4.0 Maturity Index created by ACATECH and the Digital Plant Maturity Model created by the BioPhorum Operations Group.
Pharma 4.0 and Data Integrity by Design
It’s important for the industry to shift the perception from seeing processes as separate from the current supporting and related downstream technology, and to look at the processes and the supporting systems as tightly integrated.
It’s also important to consider and care as much about how data will be used or interpreted as much as it’s created. This requires all of us to improve our understanding and accept that we must continue to develop our knowledge of data-related technology.
Data integrity is much more than ensuring that your system has an audit trail. It’s about ensuring that you have quality data that we are gathering the right data and metadata that we’re considering the entire data life cycle from creation all the way through to destruction, and that you’re upholding ALCOA+ principles.
Data integrity requires well-defined, robust, repeatable, but flexible processes. It also requires that risk management principles are taken into account, and it requires that you use critical thinking when designing and deploying systems.
What is the difference between Industry 4.0 and Pharma 4.0?
The main difference between Pharma 4.0 and Industry 4.0 is the focus on data and analytics.
In Pharma 4.0, data is collected from all aspects of the manufacturing process, from raw materials to finished products. This data is then analyzed to improve quality control, optimize production, and reduce costs.
Pharma 4.0 also places a strong emphasis on traceability and transparency, two key requirements for the pharmaceutical industry.
In addition, Pharma 4.0 takes into account the unique regulatory compliance needs of the pharmaceutical industry. For example, Pharma 4.0 includes the concept of data integrity by design which ensures that data is collected and stored in a way that meets all regulatory requirements.
Key Differences Between Pharma 4.0 and Industry 4.0
– Pharma 4.0 is the application of digital technology to the manufacturing process of pharmaceuticals.
– Pharma 4.0 focuses on using data and analytics to drive efficiency and quality in production
– Pharma 4.0 is still in its early stages of development
– Industry 4.0 has been around for longer and is further along in terms of adoption and implementation
– Industry 4.0 is a broader term that encompasses all aspects of production, from development to delivery and customer service
– Industry 4.0 is a more comprehensive solution that can be tailored to specific needs.
Where do Industry 4.0 and Pharma 4.0 intersect?
The common theme between both is that at the intersection of Industry 4.0 and Pharma 4.0 both regulatory compliance and continuous improvement are supported through the move from traditional processes to the world of digital.
A few examples of this possibility are:
1. Continued process verification
2. A paperless plant floor
3. Digital validation
4. Near-real-time batch release
Regulatory compliance is important because it ensures that products are safe and effective, while continuous improvement is also important because it helps companies improve quality and reduce costs. Pharma 4.0 supports both goals by providing data that can be used to improve quality control and optimize production.
Pharma 4.0’s emphasis on traceability and transparency can help companies meet the requirements of regulatory agencies.
Benefits and Values:
Although quantitative data on Pharma 4.0 benefits is lacking, current literature and a series of stakeholder interviews on the matter revealed that benefits can be expected in the life sciences industries specifically.
For instance, the implementation of Industry 4.0 technologies could allow real-time quality control of the production process and immediate correction of any deviations observed. Thus Pharma 4.0 could prevent the loss or long-term quarantine of entire production batches that sometimes happens in processes that rely exclusively on post-production quality control and batch release.
Overall, four distinct areas have been identified where Pharma 4.0 can provide significant improvement.
They are the following:
1. Performance and Productivity
3. Regulatory Aspects and Socioenvironmental Responsibility
4. Organizational Culture and Strategy
Pharma 4.0 offers benefits in all these areas, but the magnitude of improvement will vary from one organization to another. The main reason for this variation is that 4.0 technologies require a certain level of maturity within an organization to be successfully implemented and utilized.
Theoretically, Pharma 4.0 is still in its early developmental stages with much potential yet to be realized. In practice, however, there are already some life sciences companies that have started to fully or partially implement Pharma 4.0 within their organizations on a wide scale.
How does it save money?
Pharma 4.0 can be cost-effective because it automates and integrates processes that were previously manual and isolated.
In addition, Pharma 4.0 technologies can help companies reduce the time needed to bring new products to market. By reducing the need for testing and retesting, Pharma 4.0 can help companies save both money and time. Overall, it has the potential to significantly reduce manufacturing costs while also improving quality.
Another way Pharma 4.0 is saving money is by automating the manufacturing process. Automation can help to reduce errors and improve quality control. It can also help to speed up the manufacturing process, which can lead to significant cost savings.
Pharma 4.0 is also helping companies save money by reducing the need for inventory. In the past, companies would often maintain large stockpiles of inventory in case of disruptions in the supply chain. With Pharma 4.0, companies can use just-in-time manufacturing to produce only the amount of inventory they need, when they need it. This can lead to significant reductions in inventory costs.
Pharma 4.0 also helps companies save money by reducing the need for regulatory compliance testing. With Pharma 4.0, companies can use predictive analytics to test for potential issues before products are even released. This can help to avoid costly recalls and other problems associated with non-compliance.