Q&A with Kimberly Remillard, RAC, senior regulatory affairs manager at Thermo Fisher Scientific, examines how leveraging the power of Pharma 4.0 can ensure data integrity within biopharma.
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Q. What is Pharma 4.0 and how can digital maturity and data integrity drive it?
A. The term Pharma 4.0 is a pharma industry-focused interpretation of Industry 4.0 – focused on adopting innovative methods to deliver higher quality treatments to patients. There is an intrinsic link between Pharma 4.0 and data integrity – and therefore the systems and technologies which organisations can use to drive these strategies. The Pharma 4.0 concept builds on Quality by Design and process analytical technology. Instead of waiting to check the product only at the end of the manufacturing process, Pharma 4.0 moves to real-time monitoring, using connected systems to enable a truly agile continuous manufacturing system where processes self-adjust based on the data being collected.
Since data is at the heart of this system, it’s important to apply the latest data analysis techniques such as artificial intelligence (AI), machine learning (ML) and deep learning (DL) to enable simulations through which the system can learn and optimise product quality. Finally, Pharma 4.0 looks to automate and eliminate any human or manual intervention by leveraging software to make decisions based on information collected from the connected systems, and where possible automatically drive any actions, such as changes to the manufacturing process. This complete system creates a far more intelligent scenario, where pharma products are manufactured in a process which is constantly learning and proposing solutions to any issues that arise to enable optimum product quality.
Q. What challenges does pharma manufacturing face today and how would Pharma 4.0 combat these?
A. Now more than ever, there is an increased sense of urgency to deliver high-quality drug products in as short a timeframe as possible. More tests are required but with the same number of analysts. This drives a real need to decrease the level of manual intervention that scientists are required to make throughout all processes, and to move toward modular manufacturing where continuous adjustments and improvements can be made based on in-line sensors and process monitoring. Ever-increasing compliance and validation requirements across various global markets lead to more processes and documentation to provide evidence of the who, what, where and when of each action.
Currently, pharma and biopharma organisations use a plethora of systems to manage their labs, production environments, and their data. Enterprise connectivity is essential to bring together all the pieces of relevant data and information that could be helpful in successfully and safely bringing a drug product to market. The production and lab systems both hold critical data which are far more valuable as a complete piece – providing all the relevant people in the organisation with access to that data ensures they can make fast, informed decisions.
Where innovative technologies are adopted, they require new methods and increased regulatory checks – there is a need to ensure manufacturing organisations remain agile and can adopt new capabilities to optimise manufacturing and deliver high-quality products.
By adopting Pharma 4.0, organisations can not only connect their data to provide them with holistic information, but they are also able to quickly act upon that to make essential improvements to production."
Q. What state is data compliance and integrity at today - and what else is needed to ensure overall integrity?
A. The digitalisation of data is an ongoing transition for many organisations. As systems become more automated and digitalised, the data is often in repositories which are not centralised and created using systems which are not able to speak to one another. This often results in a dependency on a strong culture of quality, as well as manual processes and SOPs to ensure compliance and integrity. With separated systems and manual processes, the challenge to meet the data integrity levels expected with ALCOA+ relies heavily on human elements to monitor data across systems, ensure procedures and processes are followed, and identify and correct issues in a timely and effective way. This is inefficient and leaves room for errors. The more organisations that can centralise their data, the better they can enable control over the integrity of data throughout the data lifecycle.
In place of the data lifecycle being scattered across various platforms, systems, and sites, a centralised data system allows the users to view data as a whole and identify trends and inefficiencies, whilst correcting issues in a more effective way. Security of these systems is critical to maintaining data integrity so ensuring the systems being used are designed, managed, and qualified properly is an essential step to safeguard the overall integrity of the associated data.
Q. What is still to be done for businesses to reach Industry/Pharma 4.0?
A. Considering the resources required to achieve Pharma 4.0, we are looking at a culture of digitalisation to enable such an intelligent system. The workforce too must be ready to accept this way of working, with an openness to change. Organisations need to have qualified experts ready to drive science forward. The tools, devices, and IT systems need to be on an open platform to connect the necessary instruments and equipment, with common data standards and likely cloud-based to enable data sharing. The information systems are the basis of integration and traceability as well as automation, eliminating unnecessary manual or human intervention and reducing regulatory oversight. A culture of strong communication, with a leadership keen to drive positive experiences through technology, is also key. Above all, data integrity is the common theme throughout Pharma 4.0, so organisations need to look at how this can be driven using the technologies and processes available.
Q. How will Industry 4.0 impact the maturity of quality management systems?
A. As Pharma 4.0 continues to mature we expect to see this digitalisation harmonisation expand to allow pharma and biopharma organisations to manage control of their processes and materials throughout the whole supply chain. When organisations automate and integrate processes, workflows, and data collection, they allow for the ability to reduce errors and improve data integrity.
In addition to improving the quality and efficiency within pharma and biopharma organisations, one of the objectives of moving towards Pharma 4.0 is to help make compliance an automated and integrated part of the quality system. By moving toward this approach of enterprise connectivity, organisations enable a higher level of efficiency and control of the data.
By using a centralised and secure system that follows the FAIR principles (Findable, Accessible, Interoperable, Reusable), data can be evaluated and monitored in real-time. This can be especially beneficial to the quality management system processes as it provides the opportunity to monitor process effectiveness and efficiency for quality data-driven decisions. Early awareness provides the opportunity for more valuable root cause analysis of potential issues and inefficiencies, which can result in improved processes and workflows. Improving the capabilities to automate systems and reduce manual operations to build compliance into the process can improve efficiency, reduce time and effort, and allow for a more effective quality system.