What is Pharma 4.0?
What is Pharma 4.0
Pharma 4.0 (Pharma4) can be described using the same description of Industry 4.0, which isthe convergence of people, physical systems and data within an industrial process. The convergence should increase quality of the product, productivity of the manufacturing and processing of the product and profit by using the power of advanced data analytics.
If we looked at the industrial revolution as Industry 1.0 (mechanization and steam power), the arrival of electricity as 2.0, the arrival of the internet as 3.0, we can now see the infancy of the 4.0 industrial ‘evolution’ (in this case Pharma 4.0).
The impact of Industry 4.0 on Pharmaceutical Industry
Much has been written on Big Data working alongside the Industrial Internet of Things (IIoT), known also as Industry 4.0. Most of what has been written leans more toward the changing faces of transportation, logistics, manufacturing, oil and gas production and aviation.
What seems to be lacking is enough information about the effect of Industry 4.0 solutions that can be applied to the pharmaceutical industry. More specifically, the application of 4.0 solutions on pharma manufacturing problems holding back any increases in quality and productivity, while simultaneously decreasing risk and eliminating waste. Pharma 4.0 is the descriptive term applied to using Industry 4.0 specifically in a pharmaceutical manufacturing setting.
Key drivers moving Pharma 4.0 forward
Pharmaceutical manufacturers must remain competitive in a growing marketplace of increased complexity. In addition to this already demanding scenario, are regulators’ increasing push for continuous product monitoring.
Until recently regulators accepted, rather reluctantly, an annual product quality review.It was adequate though not necessarily ideal to regulators expectations. Today there is a growing expectation of increased monitoring by manufacturers who are performing such reviews on a much more frequent basis.
Pharma 4.0 technology now allows for continuous, real-time monitoring of manufacturing processes. Any drift away from preset parameters can not only be predicted, but also immediately rectified before it becomes a deviation. This process nearly eliminates associated downtime and any loss of product.
There is also increased pressure on pharma’s R&D departments to develop both, new products that run faster than in the past and also more personalized therapies.
Overview of a Pharma 4.0 site
A pharmaceutical manufacturing plant designed to meet Pharma 4.0 principles, involves machines, equipment and computers. This is now where 4.0 comes into effect.
All elements of the machines, equipment and computers that functioned under Automated Process Control (APC), a standard since the late nineties, are now fitted with multiple sensors (including individual components within them).
The sensors now will monitor every aspect of the process, including their own wear and tear. The components, unofficially called “self-aware” components, can report on their own condition. They would be able to send data on how much life they have left as a useful part as well as predicting when they are likely to fail. The down-time savings alone can recover the investment moving to Pharma 4.0.
It comes as no surprise that this inspection system will generate huge volumes of data – on average about 24 terabytes per year. As an example, United Airlines generates only about 9 terabytes per year. In order for the migration to Pharma 4.0 to be successful, all that data needs to be processed with advanced analytical tools, developed as a result of the big data evolution. Over time, Artificial Intelligence (AI) will play an increasing role in data analytics.
Pharma 4.0 Operating Models
Resources: This is the H-Factor, which defines the contribution of human capital as essential to the success of a Pharma 4.0 program. In this process, the skills and competencies of employees will be adapted and updated provided their full cooperation is in place. Implementation of Pharma 4.0 technologies allows people to focus on the value-added activities, thus leaving any of the repetitive operations left to machines. A key to the success of Pharma 4.0 in this area is the availability and qualifications of a company’s resources used during transformation.
Fewer operators will be needed with the move to Pharma 4.0 production lines but the jobs will be highly skilled.
Additionally, staff will need, (aside from their technical skills), industry knowledge and in in-depth understanding of the facility and production processes. The quality of data will improve with the increase in automation but for now it is still being delivered as a form of raw data and not quite cleaned up in a ready-to-use format. That said, your staff will still need to spend time preparing the data for analysis.
Information Systems: ERP, manufacturing execution systems (MES) and laboratory information management systems (LIMS) have been a fixture in companies for many years and are by definition today as not indicative of “innovation.” When we look at Pharma 4.0 though, all these systems will need to interact by way of a holistic value network where end-to-end traceability is the key factor driving the integration. Enabling data collection and process control through interconnectivity and interoperability along all levels of drug development would benefit in the transformation.
The value that Big Data brings is in the fact that its analytics is drawn from sources that have traditionally never been connected to one another in the past. Now connected, Big Data will look for relationships, pattern and trends that were previously undetectable.
We would take the data from the online system as noted above and combine it with the data from equipment maintenance and the engineering systems and use it to streamline maintenance schedules. Simultaneously the data collected from sales and dispatch systems can also streamline production planning.
You can achieve this to a lesser degree using Enterprise Resource Planning (ERP) tools but they would work with smaller sets of data than are created using Pharma 4.0. In effect the ERP data conclusions and recommendations would be comparatively less valid.
Organization and Process: As expected, many processes and on occasion, whole organizations will need to change in order to support implementation of new Pharma 4.0 technologies. Moving from a silo-based organization to one that with functions cooperating along various phases from product development to commercialization is a necessary change that needs to be carefully managed by companies. This involves moving from a manufacturing control strategy to a holistic control strategy. This makes a number of synergies possible within the organization; enabling increased quality and compliance to regulatory controls.
Culture: Pharma 4.0 provides new tools to all people at various levels in an organization. These new tools will enable real-time process monitoring in support of evidence-based management. An organizations culture defines its value system and is a key element to drive change. The company’s culture will need to adapt and evolve to better cope with the new challenges of a Pharma 4.0 transformation.
The four elements of Resources, Information Systems, Organization and Processes and Culture are supported by two enabling factors. The first one to be discussed is Digital maturity.
Each company will begin its Pharma 4.0 journey based on its history and experience. Assessing rh current digital maturity of a company determines the starting point and will define the nest steps necessary to implement the Pharma 4.0 technologies. A Pharma 4.0 maturity model is currently under final completion to be used to assess the initial digital maturity of the company and to monitor its progress.
Data integrity by design
The second enabling factor to discuss is Data integrity by design. This ensures the compliance and reliability of information and data exchanged across the value stream. When new processes are being designed or changes need to be made to existing ones, data integrity by design should take the lead as one of the key driving factors of the change.
Pharma 4.0 key difference with current control strategies
When introduced in the nineties, APC strategies greatly improved quality oversight. While a significant improvement, they remain to this day, by nature, reactive. They can only inform when damage has occurred. They cannot predict what’s about to go wrong, much less within a specific timeframe even.
Pharma 4.0 is much more than just process control. By increasing monitoring throughout the production cycle (not just the production line), Pharma 4.0 reveals predictive analysis and a number of other analytics to provide a wealth of business insights currently unavailable due to unstructured, dispersed, incomplete data.
For the most part, Pharma 4.0 is a risk averse industry. It maintains strong regulator support in its move towards the Pharma 4.0 approach. It will become the new standard.
These are exciting times with the changes coming and we are very happy to help you in your Industry 4.0 journey.
Contact us to learn more about how we can assist in your Pharma 4.0 Transformation: firstname.lastname@example.org