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Cold chain management, Technology
As digital transformation sweeps across the life sciences supply chain, many enterprises are using this movement to combat counterfeit products and meet the relatively recent track-and-trace regulations. As the industry comes under more scrutiny, it is more important than ever to ensure that your supply chain mitigates risks and meets the requirements.
The life sciences industry has struggled to ensure the security and integrity of its products as they are transferred between the different stops on the value chain from contract manufacturers to wholesalers to dispensers, and finally, to the patient and consumer. This is particularly true as products move across international borders, and the problem has been growing as product demand increases.
Product theft is also on the rise. More money is lost to counterfeiting with each passing year. FreightWatch International has released statistics suggesting that drugs account for approximately 15 percent of the estimated $8 billion to $12 billion of annual cargo theft, which amounts to well over $1 billion annually. This alone is bringing track-and-trace technology top of mind for pharmaceutical manufacturers.
From a regulatory perspective, the FDA’s Drug Quality and Security Act (DSCSA) in the U.S., and the EU’s Falsified Medicines Directive aim to increase the security of the manufacturing and delivery of medicines and prevent false medicines from entering the supply chain. Falsified medicines include those with little or no active pharmaceutical ingredient (API), the wrong ingredients, products with tampered packaging, and products that have been stolen for re-use or resale, and penalties for non-compliance can include criminal sanctions.
Regulators in the food and beverage sector are exploring similar requirements to give consumers added piece of mind. Starting in 2020, medical devices and products will fall under new regulations under sweeping changes that will bring a wide scope of products under its purview and require better traceability as they move through the supply chain.
The regulations outline the steps manufacturers, repackagers, wholesale distributors, dispensers (i.e., pharmacies), and third-party logistics providers need to take to develop an electronic, interoperable system that tracks a drug at the unit-level throughout the drug supply chain.
Both sets of regulations include provisions on product identification and verification, data sharing, detection and response to suspect any illegitimate products, recordkeeping, and unified licensure standards for wholesale distributors, and third-party logistics providers. Pharmaceutical supply chain partners must be able to verify that the product in their possession is legitimate, not counterfeit, recalled, or expired. Participants can be criminally liable for products not meeting the regulations.
The track-and-trace regulations generally cover three themes:
GS1’s process and verification messaging standards are enabling pharmaceutical supply chain participants to share information about movements and whereabouts of products and assets through the supply chain based on four types of events, covering most of the business processes that a product could experience throughout the product lifecycle:
Pharmaceutical enterprises and regulatory agencies are now looking at how technology can facilitate compliance with the regulations while enabling enterprises to protect the quality and integrity of their cargo due to intentional tampering and theft. Real-time temperature monitoring complements track-and-trace technology, providing mission-critical insights into the supply chain while preventing product and operational waste.
Digital technology is being developed to provide critical insights pertaining to distribution compliance, tamper evidence, serialization, and verification, helping to eliminate counterfeit drugs from the supply chain and ensure product authenticity. Since neither the EU Directive or the DSCSA provide guidance regarding the implementation of any serial number systems or data collection systems, the decision is left to individual companies. Innovative technology solutions can help enterprises accomplish what regulatory bodies set out to do with the serialization requirements.
Track-and-trace platforms are leveraging technology to establish interoperable network solutions and to digitally manage drug recalls across a digital supply chain network. The DSCSA specifies that for 2023, all participants need to have systems and processes in place to enable the electronic interoperable tracing of medicines at the package level to support suspect product investigation. This is providing a logical opportunity to improve the currently fragmented, manual processes across the life sciences supply chain, connecting and sharing critical data among stakeholders to mitigate risk and drive continuous improvement.
Controlant’s Cold-Chain-as-a-Service solution complements the track-and-trace regulations by providing critical temperature monitoring and product movement traceability information in real-time through a single, centralized platform that can be accessed by multiple supply chain stakeholders. Controlant’s system can integrate into other systems, including enterprise resource planning software, connecting key data points together. Businesses can track key supply chain metrics, including lane modality used (air, road, rail, or sea), packaging type used, product shipped, and the supplier or logistics partner managing the product.
Internet of Things (IoT) data loggers collect critical pharmaceutical product data, sending it to a cloud-enabled software platform. Sensors can detect light events that suggest unexpected behaviors, including tampering or theft. If a deviation occurs, stakeholders are immediately notified by alerts sent through the platform, and via SMS and email, so that corrective action can be taken. For instance, a truck door may not have been properly closed, causing reefer temperature to increase above accepted boundaries. An alert is sent, the carrier and driver are contacted, and the door is subsequently closed, preventing product integrity from being compromised. Alternatively, a truck door may have been opened unexpectedly, and products are stolen. The time and location of the light event can be traced in the Controlant system to support the investigation process.
Enterprises can connect temperature and location data to track product conditions in real-time as they move throughout the supply chain. This facilitates root cause analysis and helps to reduce investigation time. For instance, products traveling by sea freight might be re-routed unexpectedly to another seaport that is not validated for pharmaceutical purposes. With a standard temperature data logger, which doesn’t provide live product location traceability, this information may never have been known. Having the information available would permit quality teams to review shipment data prior to reaching the port.
Through a single, real-time temperature and product movement visibility solution, data is owned by the customer, including pharmaceutical manufacturers and freight forwarders, and can be shared with additional stakeholders through user-permissioned access to data that is limited only to a part of the supply chain.
Over time, enterprises gain access to key performance metrics regarding their supply chain, facilitating risk reduction and proactive, continuous improvement that can substantially reduce costs and waste.
Patient safety is at the core focus of the traceability of products as well as managing temperature compliance, although pharmaceutical manufacturers and enterprises have valuable cargo at risk. Real-time temperature and location data complement the track-and-trace technology, providing additional insights that can help stakeholders identify which products were impacted, where and when it happened, and why.
As regulatory requirements evolve and the healthcare industry is constantly growing, there will be a greater risk to patients if technology adoption does not evolve quickly enough to meet the industry’s changes.
Real-time visibility technology provides the key quality data needed to complement the track-and-trace requirements, enabling enterprises to proactively ensure the quality and integrity of their delivered products.