Pharma 4.0: quality management in the digital age
Robert Gaertner, director strategy, Veeva QualityDocs, looks at the way that digitisation has changed life sciences and what the future holds, including technology development and upcoming regulatory requirements
Today’s pharmaceutical companies are moving away from the ‘one-size-fits-all’ approach, recognising the need to develop more personalised treatments. However, traditional manufacturing and quality functions will struggle to keep pace with this necessary innovation in personalised therapies unless there is a change. This is where ‘Industry 4.0’ as the next big trend has potential to revolutionise pharmaceutical operations from the inside.
Increased cost pressure and greater global competition require a different approach. Companies are starting to combine drugs, advanced application devices, and medical apps to be more patient-centric. However, previous product launch approaches, process technologies, and proven validation concepts are no longer sufficient, as they have an increasing number of product variants and smaller batch sizes.
Enabling personalisation of medicines requires more than putting a nice wrapper around the same processes and systems that have been in place for decades. Digitalisation will play a strategic role in all aspects of the new value chain, from R&D to manufacturing to patient-centric information exchange. Industry 4.0, therefore, is not only about new technology, but also domain-specific concepts and standards that transform supply chains, manufacturing facilities, and processes.
This technology leap will lead to disruption, which brings with it a level of uncertainty. But this uncertainty cannot be an excuse to halt progress. And no other industry is more prepared than the pharmaceutical industry to analyse critical processes, assess risks, and define controls. This is where the quality organisation is critical to a digital revolution. As a result, it is essential that quality professionals gain a deep understanding of information technologies so they can advise on how to best implement them in a timely and compliant manner.
From Industry 4.0 to Pharma 4.0
The vision for Industry 4.0 is to connect all resources – human, data, and physical machines – in one virtual network. This connectivity is both within and beyond company walls; the most benefit will be achieved by going beyond plant walls.
Industry 4.0 combines diverse technologies, including big data analytics and cloud computing. The ability to analyse enormous data volumes and share insight across the virtual value chain will be important to delivering new innovation and responding to changing market dynamics. Content and data are stored in a regulated cloud repository so information can be accessed in real time from anywhere.
By applying the concepts of Industry 4.0 to the pharmaceutical industry, “Pharma 4.0” is both revolutionary and transformational from the outbound flow of goods to the information flowback of real-time patient data.
Impact on quality organisations
The trend towards more individualised therapies means more quality data to review and more releases to support. With this comes more pressure on quality to avoid being the bottleneck in a make-to-order world.
Realisation of Pharma 4.0, however, requires a shift in how GxP content and data are managed. Today’s approach is still greatly based on paper and a traditional definition of documentation needs. This slows down processes and is limited when it comes to efficient knowledge sharing and collaboration across multiple parties.
Transformation needs to start with changing the mindset and perception of GxP content:
- Electronic content is not just “paper under glass” – Many enterprises think they have state-of-the-art execution systems, but those systems still support paper-based processing for GxP record-keeping. Looking ahead, GxP-compliant documentation will arise in new electronic formats, which cannot be properly managed with legacy paper-based processes.
- GxP and non-GxP data management will merge – GxP relevance to records and systems will be defined by usage, not physical separation (e.g. multiple paper/file copies). This means classification as GxP or non-GxP will not be feasible anymore, and this requires security mechanisms and controls for non-GxP areas.
- Global collaboration and content exchange are musts – The goal is no longer to isolate content and data behind company walls, but rather to facilitate a secure exchange among a virtual team. Team set-up can change quickly, and processes may need to be reconfigured. Therefore, it is important to not only grant access to external parties on a granular level, but also to revoke access in a flexible, secure fashion.
The trend towards personalised therapies requires a transformation – one that supports the shift from inflexible mass production to manufacturing individually tailored products with the expected quality, safety, and efficacy. A Pharma 4.0 approach is needed to support this shift. Quality needs to mandate the assessment of risks and the implementation of effective controls to open the doors to Pharma 4.0.