Traceability and the changing the face of Pharma/FnB
In today’s business environment, the ability to “Track and Trace” is becoming an increasingly urgent necessity and a key differentiator in many industries, the most successful cases in point being the FnB and Pharmaceutical sectors. Track and Trace can be broadly defined as the capability to determine present and past locations of products through the whole supply chain lifecycle. In the era of competitive economic climate, even a small advantage can quickly snowball into a major segregator, as a business owner, the veracity of the statement can easily be experienced in the areas of enhancing pilferage reduction, counterfeit prevention and targeted recalls, thereby significantly improving supply chain efficiency, synchronization, visibility, and security. The pharmaceutical industry, together with the food industry, is one of the most advanced in traceability system implementation, as it has traditionally been strongly affected by counterfeiting attacks.
Let’s put some words around the terms “tracking and tracing”. Essentially, ‘tracking’ means, knowing the physical location of a particular good within the supply chain at all times and ‘tracing’ means, keeping continuous monitoring on rapidly changing regulatory environment, resulting in an increasingly strict control of shipment handling. For drugs and food in particular, various regulatory practices and market legislations, are pushing companies to align both production and distribution processes, traceability requirements, to avoid non-compliance. F&B and pharmaceutical industries have proven to be highly sensitive to “track and trace” related issues. Objectives like —patient care and safety, for Pharma, and offering wholesome, fairly priced, ethnically diverse food options for F&B, is constantly being threatened by forgery, theft and spoilage and leads to the fragmentation of the pharmaceutical supply chains and credibility and profit reduction in F&B. In both of these sectors, since there is a growing multitude of wholesalers and retailers involved, and the shipments flow through a large number of physical hops, it enables rapid development of secondary illegal markets, thereby collapsing the efficacy of investing in a robust supply chain solution.
Radio frequency identification (RFID) technology, 1D or 2D barcodes placed on packages and containers, its benefits, and impacts, in the form of its adherence to international standard for implementation (Electronic Product Code – EPC) and serialization (GS1), has moved to item-level traceability implementation and to the definition of continuous traceability systems. Manufacturers now have to change the way they package, mark, and label their products, including redesigning packaging to accommodate new barcodes, serial numbers, and anti-tampering features. At each exchange between manufacturer, wholesaler, distributor and retailers in healthcare of FnB sector, need to be responsible for tracking, tracing, and documenting shipments using identification numbers linked to items at the case, pallet, lot, or batch level. As a result, existing enterprise application suites such as ERP, dedicated logistics and transportation suites and QMS, while sharing common datasets incorporated through serialization architectures, need to offer multi-enterprise visibility or traceability, often driving serialization leaders to build capabilities such as “track and trace” and “verification and authentication” in a separate application layer.
The task of supply chain management is a very complex task, one of the much invested technology enablers has been in applying Geographic Information Systems (GIS), which automatically reduce the complexity by bringing out subtle geographic patterns and relationships that can form the basis of good decisions. Systems like ArcLogistics Route can take pain out of applications like Vehicle Tracking and Dispatch, Route Analysis, Warehouse Operations, Facilities and Depot Management, Routing and Scheduling. GIS analysis is more than the use of mapping software or the ability to plot points on a map. It is the ability to draw relationships spatially and to identify value in each relationship. An example would be the ability to follow product through its assembly process by locating key component supplier locations and routes from the supplier to manufacturing plant, and then from the manufacturing plant to distributor and then to the customer. In enabling this technology to transform modern supply chains GIS layer is now encapsulated in web services, to mostly provide a vendor-neutral interoperable framework for web-based discovery, access, integration, analysis and visualization of multiple online geospatial data sources.
Some of the more common GIS queries relevant to supply chains could be:
What is the drive time from the central facility to any other location?
How long will it take to reach delivery locations?
Which customer will be in which service area?
How can the goods be tracked through the supply chain? What will be the shortest route between two points in the supply chain network?
What will be the alternative path between two points other than the normally followed shortest paths?
Complex architectures based on newer enhancements of robust technologies such as RFID, GIS etc. have emerged. Adoption of Serialization Line Master Systems and Aggregation Clusters, by countries like Turkey and China are leading the way for communication of the exact serial numbers of the units sold, to the Ministry of Health or FDA, as the case maybe. The landscape changes frequently as new economies started participating in the formulation of legislative and technological aspects of track and trace, and its impact on mass production processes.