Gaurav Mohite, global product Manager, Track & Trace at ACG Inspection Systems discusses why aggregation is essential for helping tackle counterfeit medicines.
Counterfeit
Aggregation is one of the most important topics in pharma manufacturing right now, particularly when it comes to tackling fake medicines and anti-counterfeiting. It is a crucial part of the ongoing advancement in technology solutions to improve security, visibility and communication in the pharmaceutical supply chain.
Why now?
Aggregation is building relationships between different products at varying packaging levels. Put in simpler terms, it is also known as establishing parent-child relationships between product packaging levels.
The EU FMD regulations ensure customers can authenticate product as genuine using safety features (unique identifiers and anti-tampering devices). Whilst this is a huge step towards eliminating fake medicines being introduced to the supply chain, the scheme has its limitations, including the lack of ability to securely monitor and track products within the storage, shipping and transportation processes.
Thus, full end-to-end track and trace systems are the next step in the advancement of security in the supply chain, with aggregation playing a key role in these. By implementing aggregation functionality, alongside information exchange, a product’s path can be securely tracked through all supply chain partners who are integrated in the track and trace eco-system, from manufacturer, to warehouse, wholesaler to distributor, retailer and, finally, the end customer.
The benefits of aggregating go beyond anti-counterfeiting for all involved in the supply chain process. Implementing aggregation in a track and trace solution supports the following developments:
- Enabling manufacturers to cater to multiple countries’ track & trace requirements.
- Enabling all supply chain stakeholders to improve inventory tracking and management.
- Improving ease of shipment, commissioning and decommissioning of cases and pallets.
- Generating more efficient, simplified product recalls or returns, with complete visibility.
- Increasing transparency in the pharmaceutical supply chain.
- Data received from the aggregation can be also used for future planning and monitoring activities, helping further improvements in efficiency.
Global regulation status for aggregation – working towards one solution
Whilst Europe has implemented serialisation at the unit packaging level under EU FMD, as yet aggregation is not required. However, the European Medicines Verification Organisation (EMVO) is currently undertaking a study to determine the most effective way to support the concept of aggregation/consolidation within the overall European Medicines Verification System (EMVS) system. An update of functionality to support this would have a major effect on all aspects of the EMVS system and therefore the EMVO needs to undertake an evaluation considering security, effectiveness, and overall cost aspects. We are expecting the EMVO to plan for the EMVS system upgrade to support aggregation functionality after their detailed study of aggregation methodologies and associated security aspects over three to five years. The EMVO is also expected to share guidelines for manufacturers at regular intervals.
To an extent, whether or not the EU has mandated aggregation matters little when customers are located around the world, many in countries where aggregation is, or soon will be, mandated. Therefore, European companies which are slow to introduce aggregation into their production and supply chains, will struggle to meet ranging global regulations and be left behind.
Multiple companies in Europe are pro-actively implementing aggregation solutions into their production lines, yet there is more work to be done to reap the full benefits of this system.
Aggregation’s role in anti-counterfeiting
Clearly, aggregation plays a key part in a comprehensive track and trace solution. It works alongside serialisation, data sharing and reporting, to allow supply chain partners and governments to have complete visibility of the pharmaceutical supply chain and to identify the sources of counterfeit goods and associated incidents.
The discipline of the aggregation process will also tighten up operational practices and help manufacturers to strengthen checkpoints in the packaging process, therefore offering guarantees for stakeholders at every point in the supply chain. Additionally, implementation of aggregation will strengthen the packaging and shipment processes. All activities related to product association with consignments will be logged and tracked, which makes it difficult for any stakeholder to introduce counterfeited products into a supply chain. Moreover, it eases the burden of ensuring the security of products. For example, if you ask yourself whether you would like to scan 1,000 products inside a pack independently one-by-one, or to scan one code to get detailed information of all products inside the pack, the answer is going to be the latter. Without aggregation, we need to physically open and investigate the contents of consignments to verify what is contained within a shipment. Aggregation removes the need to open the case and scan all individual saleable units – saving critical time. Removing the need to open shipments also makes it challenging for counterfeit products to enter the supply chain. This represents one of the ways aggregation can facilitate the material handling aspects of serialised projects in warehouse environments and create efficiencies across the entire supply chain.
Challenges faced by manufacturers
Any focus on aggregation should highlight that its integration into the production and supply chain can pose challenges for the manufacturer. Aggregation is a complex process and requires not only a financial investment, but also time.
Integration impacts on manufacturers packaging level equipment, processes and standard operating procedures (SOP’s) during set-up. Production may be impacted if not properly planned for. When it comes to serialisation and aggregation implementation, manufacturers need to transform their packaging line with additional equipment, establish processes around these new systems, and educate operators through training and SOP’s, in order to adhere to these new procedures.
Once implemented, aggregation processes then need to be followed throughout the production process. In the case of any alterations or reworking, additional activities need to be adapted. Following the implementation of aggregation, whatever happens on the production line regarding product packaging needs to be recorded and monitored through stringent processes.
Each packaging level will also require a different aggregation solution depending upon the line configuration. Manufacturers need to consider alternative packaging lines with old and new machines, automated or manual processes, and multiple packaging configuration to deliver. As such:
- High speed automated lines need aggregation solutions to be integrated inside automated packaging equipment. For example, a camera system located inside a case packer.
- Mid-range speed lines (generally known as semi-automatic configuration), need standalone equipment to meet line speed aggregation requirements with manual intervention.
- Low-speed manual lines require simpler and compact solutions e.g: using handheld scanners.
Warehouses and distributors also need to be equipped with the relevant tools and training to read the serialisation on aggregated shipments and share the data with supply chain partners. Again, this equates to set up costs and time. It’s important to note that data reporting to the EMVS is one part of the aggregation functionality, but actual implementation at production lines involve major efforts from the manufacturers’ end.
Preparing for aggregation implementation
Implementing aggregation solutions in a manufacturing line is a learning curve and a manufacturer needs to evolve its processes around it. However, there are a range of actions companies can do to offset the disruption and prepare for this important step in tackling anti-counterfeiting and improving efficiency in the pharma supply chain:
- Be proactive and start preparation early.
- Start with a pilot project to understand the complexities, as well as the impact on production lines.
- Set-up cross functional project teams involving representatives from all stakeholders.
- Use global standards while implementing and focus on security aspects.
- Involve supply chain partners (CMO, Warehouse, Distributors ec), while finalising implementation requirements.
- Select a reliable, experienced and adaptable track and trace partner for implementation who offers skilled service support and solutions – preferably offering global coverage with dedicated regional teams.
- Consider remote monitoring and management services for your track & trace server and database, in order to meet IT challenges head on.
- Assess each packaging line’s aggregation requirements independently and select appropriate solutions with cost impact in mind
- Provide special attention to education and training operators, establishing processes and SOP’s around aggregation requirements. Evaluate all use cases for packaging operations.