By David Haug (Uhlmann), Marco Steinkamp (Movilitas)
Industry 4.0 continues to disrupt the way business gets done as we continue to move from basic computerization to connected digitization. New technologies are forcing us to think and work non-linearly through the power of networks. One of the challenges to creating end-to-end visibility is the lack of standardization of connectivity. If the language isn’t the same or cannot be interpreted, then the flow of data and communication between systems can be impeded.
Pharmaceutical companies have an additional challenge of having to comply with various regulations. To meet these requirements, end-to-end traceability is needed to create an audit trail from ingredients to the shop floor to delivery destination by incorporating track and trace system data. This extended digital supply chain is often known as Pharma 4.0 because it supplies data throughout the products’ life cycle.
Prescribing Industry 4.0 for Pharma
The International Society for Pharmaceutical Engineering (ISPE) notes that “While Pharma 4.0 has been called a new industrial revolution, its implementation will more likely resemble an evolution in which digitization and automation meet very complex product portfolio with long life-cycles.”
While a Forbes article states, “The most basic implementation of traceability at [the manufacturer level] is usually by extending the functionality of their Manufacturing Execution Systems (MES) to track the lot codes of individual components as they are tied to the final unit’s serial number. This type of traceability is critical for being able to track down issues and changes after the fact, and enables manufacturers to compare key metrics, such as yield, across multiple component vendors or over time.”
For pharma, it is also about extending the traceability to batches, products and shipment after they leave the factory until they reach their destination, such as a pharmacy. To reach this ideal automated and visible state, companies need to integrate their connected production systems with track & trace solutions.
Two Systems, One Goal
Pharmaceutical manufacturers face the threat of counterfeit medicines in the market that undercut sales and put patients at risk. They need to ensure the authenticity of their ingredients as well as their quality. Any falsified goods, whether it’s a component or a knock-off, may also damage the brand’s or company’s reputation. However, governments across the globe are the main drivers for wanting to trace medications. They have implemented and continue to draft regulations to protect consumers.
On the production side, these and other regulatory requirements add a layer of complexity for manufacturers, especially if many of the processes are manual and/or paper based. Manufacturers can connect their product-related operations, such as the production machines, the packaging machines and SAP Manufacturing Integration & Intelligence, with their ERP system, and other stakeholders. Pharma 4.0 will make it possible to gather and analyze data, resulting in faster, more flexible, and more efficient manufacturing processes to produce higher-quality goods at a reduced cost.
This digitization also provides greater visibility for production and traceability of produced goods. The result is the creation of a single point of truth about batch-related production data, item-level data and shipment records that anyone with permission can access.
Track & Trace
A global track & trace system offers a holistic, transparent view of your supply chain including information from other stakeholders. It enables real-time data and response so you can manage by exception instead of having to monitor shipments constantly. Solutions help trace material provenance from raw ingredient batch origin to finished product across the material value chain.
Serialized products help with traceability as it is captured each time the item, package, pallet, etc. is scanned throughout its journey and therefore always trackable. However, many manufacturers do not often connect this information to their production lines. The data would be valuable to production teams because it bridges the gap between production planning and the global market demands. The trusted chain of uninterrupted data can assist in determining future demands, quality issues and other market trends in advance.
Realizing Full Traceability
The connection between the manufacturing process and product traceability is serialization. When their system data is combined, it helps pharmaceutical companies manage their capacity management dynamically. This flexibility to balance resources, product supply, demand and assets in a way that raises customer satisfaction while reducing costs from cutting out inefficiencies.
The collated information raises product visibility throughout the supply chain. Pharma 4.0 enables better planning, waste reduction and improved cost management. The standardized connectivity provides a 360° view for efficient control systems. This single source of trust allows key stakeholders to understand implications of potential business changes and what areas they might affect.
For more information on this concept, download the Movilitas-Uhlmann guide and unlock new opportunities with Pharma 4.0 & traceability data.