Nearly 40% of drugs consumed by Americans are made overseas, while 80% of the underlying active ingredients are sourced from thousands of manufacturers across more than 150 countries, according to the Food and Drug Administration (FDA). Place these statistics against the backdrop of a rapidly growing global marketplace for fake drugs, and the urgent need to effectively control and monitor the distribution network becomes crystal clear.
FDA’s multi-tier DSCSA mandated sharing of loT-level (shipment level) traceability with each member of the value chain in 2015, individual saleable package serialization by 2017, and verification at the point of dispensing by 2023.
European Union’s (EU) package-level serialization requirements, including support for global and national identifiers, and strict uniqueness regulations, will come into force in early 2018.
Pharmaceutical drugs traverse a long, complex path through the supply chain before reaching the end consumer. In the absence of strong controls and a robust chain of custody processes, they become easily prone to counterfeiting, theft, and illegal diversions, leading to financial and reputational losses for manufacturers. The more deadly consequences include risks to patients’ lives and long-term health.
While we are a long way from securing every step of the global supply chain, we can build our first line of defense against spurious products through effective serialization. By assigning a unique identification number to every saleable product, you can track a given product’s movement across its lifecycle, from the plant floor to the consumer.
The business case for serialization
Serialization has become a highly complex process today, partly due to the track-and-trace regulations introduced across different jurisdictions, including the FDA’s Drug Supply Chain Security Act (DSCSA). To comply with these laws, organizations will need to make substantial investments in infrastructure, applications and business processes. And, upgrading a single packaging line alone can entail significant costs. However, by designing and implementing a well thought out serialization strategy, will not only ensure full regulatory compliance, but also generate superior return on investments by reaping multiple other benefits.
Foremost benefit that the manufacturer will reap is in enhanced brand value of its products. By ensuring that only good quality drugs reach the patient, the organization will dramatically enhance patient safety and also the brand value.
Structured, tagging of products right from pallet to case to carton will foster enhanced supply chain planning and operations, including optimization of warehousing and packaging processes. The vast amount of information captured by serialized products can be harnessed for improved decision making, and support advanced data analytics.
Next, consider the near-real time inventory data that would be available at your fingertips in a serialization-driven supply chain. Companies can use this data to optimize inventory levels, avoid stockouts through quick replenishment, and make outbound and reverse logistics more efficient. The pharma industry can even perfect its sales and marketing tactics, based on a comprehensive analysis of the performance of various market segments.
A serialization roadmap
While the multi-tier DSCSA gives companies another seven years’ time to ensure complete supply chain serialization, the November 2017 deadline for individual package identification is not far away. So, they should look at the serialization journey as one comprising several phases, based on a thorough evaluation of the functionalities, technical components, interfacing, and cost of underlying IT solutions and infrastructure.
I suggest you break down this long-term project into the following key milestones, in order to successfully execute a serialization program, without breaching timelines and budgets:
- First, understand the compliance requirements, and upgrade your packaging lines accordingly; invest in new equipment such as mobile RFID printers that can produce the requisite 2D bar codes on all packaging
- If you outsource production, or are a contract partner, determine how you will manage or share the cost of the upgrades with your allies
- Plan for product label changes to accommodate 2D bar codes, and get FDA approval for the new design
- Integrate new technologies with your existing enterprise systems, and also bring each of your supply chain partners on board
- Adopt a common platform, or network data exchange solution, to generate, track, share, and store serialized information, without any business disruptions
- Ensure that the solution supports regional data specifications, as well as GS1 EPCIS, the global standard
- Go for a flexible and agile solution that would facilitate robust data archiving and master data management
The success of your efforts will hinge upon rigorous project management and accurate data analysis. Ultimately, the outcomes of a serialization initiative will depend on how smoothly an organization can integrate all the various associated technologies and processes–including those pertaining to its supply chain partners.
This is where the Internet of Things (IoT) can play a major role in fostering a truly connected serialization ecosystem by institutionalizing real-time, advanced track-and trace capabilities.
Smarter and safer drugs with IoT
A ‘smart’ pharma value chain, where every component, packaging line and factory is connected round the clock, presents immense opportunities for better, cost-effective tracking of drugs’ pedigrees and transaction histories. Leveraging the IoT to foster such an environment would enable real-time exception management and effective asset tracking, apart from significantly reducing the risks of counterfeiting. How? By embedding products with next-generation IoT software, GPS sensors, actuators, RFID tags, environmental controls, and data communication capabilities. You can also use automated information data collection (Auto-ID with AIDC) for smart serialization.
Furthermore, companies can create a truly connected drug production ecosystem by embracing automation for various phases of the discreet manufacturing cycle, from controllers, I/O systems, motors and drives to human machine interfaces (HMI).
Finally, you should bear in mind that the very cornerstone of any IoT strategy, in the context of serialization, is data analytics. To glean actionable, accurate insights from the deluge of data tracked across the supply chain, you must mine real-time streaming data, as well as stored historical data. Add to the mix robust data encryption capabilities for shielding sensitive, proprietary information–and you will be well on your way to delighting regulators, supply chain partners, and your patients.
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