Serialization 2.0: Are you prepared for it?
Serialization has come a long way from just labelling packages with serial numbers. While the deadline for serialization compliance is already over, supply chain stakeholders are yet to cover milestones pertaining to it that await them in the future. Serialization has come to mean a lot more to the stakeholders now; It is not just a way to track the location of a drug in the supply chain but also enables a global diversity in the supply chain to be able to adapt to the protocols that are outlined by the FDA and the European Union Falsified Medicines Directives (FMD).
While technology is just one aspect of Serialization, deep knowledge in the operational protocols along with a foolproof implementation plan must be considered too. It is an ongoing process that needs continuous investment and attention. Now, the main focus is on the package and unit-level serialization so that must comply with the DSCSA’s saleable returns mandate.
However, that is not all. Serialization is now being linked to every aspect of the supply chain, such as line aggregation, interoperability, drug traceability and VRS processes. So, can we call it the next level of pharma traceability? A level ahead of conventional Serialization?
Defining Serialization 2.0
This advanced level of serialization derives knowledge from its predecessor, learns from its mistakes and mines data to improve its performance in any given supply chain ecology. Aggregation is used in conjunction with serialization to characterize what we can call advanced unit-level serialization. We have already discussed all about it here: Why you Need to Take Unit-level, Lot-level and Package-level Identifiers More Seriously!.
Moving towards item-level serial numbers, Serialization 2.0 enforces data integrity through a process of strict adherence. The process helps in enhancing the control of manufacturers on their products and the internal operations, leading to improved efficiencies that can significantly save costs.
However, the benefits go beyond just saving costs. Some of them being:
-Resolving inventory leakage
Drug packages cover long distances to reach the end-user and are often subject to labelling issues, theft, quality sampling, human error and misplacements. Identifying the lost packages under batch packaging is impossible. But with unit-level packaging or aggregation, a single scan of the pallet can connect it to its child, thus identifying the zone of dispute. Once the identification has been done, corrective measures can be taken.
-Print and template management
Serialization 2.0 oversees operations at a minuscule level. For instance, addressing product recalls due to mislabelling. Although a very common problem, it can lead to volumes in product return adding to the capital cost of producing drugs. Printer labelling and management and inspection is an integral part of serialization 2.0, allowing manufacturers to ensure that each of the products is labelled correctly.
- Automating inventory reporting and reconciliations
Like its predecessor, it continues to save man-hour capital costs in manual counting and data entry, only at a greater speed. This drives a higher degree of accuracy and timeline when it comes to inventory reporting and management.
- Managing packaging assets
In Serialization 2.0, root cause analysis of a supply chain can be done by the serial numbers of products in a drug production line. Data collected from serialization can be curated and managed to gauge the efficiency and capacity of an internal production line. The overall equipment effectiveness can be monitored with a greater level of accuracy. Line aggregation is fast gaining pace with the requirements of Serialization 2.0 in linking single units to the pallet and building a child-parent relationship.
Why is Serialization not enough?
It would be judicious to accept that the drug distribution channel is still not safe, irrespective of the changes drug companies are bringing in their supply chain processes. It is a general consensus that drug companies have all paced up with the compliance demands, put equipment in place and have got the right traceability software. True, but if we consider the percentage of participants who have adopted technology for DSCSA compliance, which account for only 20%, there’s little reason to be happy about. Moreover, interoperability in the supply chain is yet to be established.
We have already discussed how important aggregation is for the smooth functioning of a drug supply chain, eliminating every possibility of counterfeit infringement. However, many manufacturers noting that aggregation was not a DSCSA mandate skipped the process or postponed it to save costs. This creates a massive gap when the un-aggregated lots sent by them to the wholesalers who have the capacity and the necessity to implement aggregation; resulting in the latter rejecting the entire lot.
On second thoughts, accepting un-aggregated items is nothing short of a risk. Owing to the influential counterfeit market that runs parallelly with the mainstream drug market, fake drug infiltration at any stage of the supply chain is not impossible. So, the wholesaler is not wrong in accepting the lot.
We have established how important Serialization 2.0 is, but no process is devoid of loopholes, sometimes for the technical reasons and sometimes for the participants who have to accept a process. This brings us to our next section- the challenges that come with 2.0.
Challenges of Serialization 2.0
Disparity in operations: Riding two boats at a time can prove to be dangerous. You might lose both. And that is exactly what’s happening with the pharma supply chain now. The DSCSA set the rules for complete compliance in 2013 and set a 10-year staggered timeline so that each stakeholder of the drug supply chain can fulfil the requirements pertaining to serialization and VRS compliance. As stakeholders take time to become compliant, drugs that are non-serialized and still running in the supply chain, get held up as a “suspect” with participants who already have DSCSA-compliant system in place. This leads to increasing levels of negative returns, causing capital loss.
Lack of awareness: Many of the stakeholders, who are either mid-way or just starting to deploy serialization software have held their decisions because of a misunderstanding. The fact that Serialization 2.0 is just an extension of its predecessor is not clear with them. They feel that this might be another of FDA’s changing protocols, which requires added investment and attention. The fact that Serialization 2.0 is a mere concept that thrives on all the processes involved in a supply chain is yet to be understood. Lack of knowledge and apprehension about the same is, therefore, holding back participants from going ahead with the process.
Involvement of smaller drug sponsors: While lack of awareness is one part of the challenge in the implementation of Serialization 2.0, the other half is ridden by smaller drug sponsors who display a dual issue of lack of awareness and aversion to seek outside help to resolve the challenges they face in implementing Serialization 2.0 because that would include cost and time.
Just like every technology has a loophole, every loophole has a way to be resolved, which brings us to our expert recommendation section.
Recommendation
When there’s a lot of apprehension and hesitation in adopting a process, it is best to adopt a single flexible solution that can maintain its performance in any supply chain ecosystem. AR-driven multiscanners, mobile-edge traceability suites, interoperable communication systems, and cloud database are some of the common recommendations experts have to give to all the participants who are still hesitant to adopt the processes.
Multiscanners act fast and handle multiple consignments easily, capturing data and storing them in a cloud data repository, which is easily accessible, flexible and expandible. Whatever be the data requirement, they can be accessed easily anytime, anywhere. TrackTraceRX, a traceability suite is a unique product in the market, which empowers the VRS process and tracks the location of the products in the supply chain. The serial number, whether, 2D or Datamatrix, is easily readable by the multiscanner, eliminating the chances of negative returns and improving revenues.
But why are we speaking of recommendations for all the stages of traceability? Because error-free serialization is an important element in all the stages, calling for a staggered and gradual development of assets across the supply chain. To put it simply, Serialization 2.0 is the combined evolution of saleable returns, traceability and the drug distribution channel.
Conclusion
It is not left to anyone’s imagination that developing a cross-line consolidation of serialized product and operations data is vital to get the most out of one’s serialization investment. This ensures better data integration in internal processes as well as outside entities, like regulatory bodies. It also provides new analytics and reporting opportunities for better operational excellence. Serialization 2.0, no doubt, transforms serialized data from a static compliance repository into a dynamic business-changing engine.
