Emerging Pharma Landscape towards Pharma 4.0

Industry 4.0 is a buzzword in many industries today. While Industry 3.0 was about process automation, Industry 4.0 is more about leveraging digital data to make smarter decisions through predictive analytics, artificial intelligence, and machine learning.

In line with the general industry “Version Upgrade,”the Pharma industry is also progressing. For Pharma, patient safety is the key objective, apart from the other industry objectives of productivity, personalization,and leveraging AI. It is of utmost importance that digitalization efforts continue to be aligned with this priority.While there is an equivalent of industry 4.0 for Pharma, well known as Pharma 4.0, the objectives are quite different and interesting to note.

In 2005,Dr. Janet Woodcock, Principal Deputy Commissioner of the US Food and Drug Administration (FDA), stated in her vision statement on pharmaceutical risk-based cGMPs for the 21st century as “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight.” Since then, the Pharma industry has adopted robust digitalization techniques to align with automation as a thought process. It in turn forms a good platform for meeting Pharma 4.0 standards.

Pharma companies are now aiming to bring their manufacturing units to the next level through automation and integration, all the while keeping patient safety in mind. Pharma regulators are raising the quality bar and strongly suggesting that Pharma companies be self-regulated.This will potentially reduce the need for quality surveillance by the regulators through audits.

In line with their thought process, US FDA collaborated with ISPE (International Society for Pharmaceutical Engineering) and introduced guidelines called “Quality Metrics” to look at various quality parameters like lot acceptance rate, complaint rate, CAPA effectiveness, process capability, etc.

Technology to Enhance Patient Safety

Pharma 4.0 inclines more toward converting data into crucial information that would

•drive patient safety,

•reduce the number of failures through historical data analysis, and

•achieve quicker turn around through Machine Learning and prediction.

•Improve quality culture

As rightly advocated by many experts, Pharma 4.0 is Digitalization + ICH Q10. Regulatory compliance should be part of the digitalization roadmap to ensure quality and reduce the risk of non-compliance.Though the introduction of Quality Metrics intends to ensure patient safety, it is a compelling case for automation. There is a need to gather complex data from each process/operation and every GMP (Good Manufacturing Process) area to derive Quality Metrics.Having digital data on hand makes this simpler.

Where to Start?

The starting point to move towards Pharma 4.0 is clean digital data. Clean data is accurate, available, and actionable. Data integrity enforced by systems is key to ensuring clean data. It goes without saying that partial digitalization of all processes or full digitalization of only a few processes will not fit the bill for Pharma 4.0.Digitalization that ensures clean data from all departments will be crucial. Then, the collected data can be turned into smart information upon which further intelligence can be built.

While data is acquired through the automation of various processes, it tends to form silos of information. Integrating the data points is key to breaking down silos and bringing all the data together. This empowers organizations to look at inter-dependencies and correlations.

Having such a foundation of clean, integrated, digital data will pave the way for further analytics, automated decision making, machine learning, predictive analysis, and assisted AI.

How to Progress?

Understanding the importance of data integrity and availability of data highlights the need for integrated platforms. Pharma companies have departments taking care of sample analysis, quality management, manufacturing processes, packaging, etc. An integrated quality management platform allows the integration of applications at every level. The data flows freely between departments to address quality and other concerns. It facilitates fetching data from applications into one warehouse. The data can then be cleaned and made available to derive quality metrics and predictive analytics. Digitalization and integration ensure data integrity and bring products to market quickly.

Quality culture is another aspect that is a need for Pharma companies. Pharma 4.0 emphasizes that by slicing and dicing data and throwing light on the weak areas where most quality issues are surfacing. It helps companies to build a strong quality culture by addressing the problems and training everyone involved.

Smart Factories of the Future

Pharma 4.0 aims to build smart factories where quick business decisions can be taken based on historical trends, there by getting predictive analysis. Manufacturing facilities can double down on process efficiencies with the increased use of digitalization tools, robotics, and automation of repetitive processes. The focus is on achieving a high sustainable ROI. The result is improved efficiency, enhanced quality, and flexibility to bring a controlled change.

Overall, Pharma companies are adopting Pharma 4.0 standards beginning with small workflow automation steps. Robust digital tools are driving them closer to their goal.The industry “Version Upgrade” is happening steadily and will pick up the pace with integrated platforms paving the way for clean data and self-regulation. It will enable Pharma companies to speed up the production of quality products for patient safety.