Pharma T&T (Tracking and Tracing) with Serialization: Challenges and Implementation
The creation of new, patient-centered medications is to blame for the increase in Tracking and Tracing (T&T) systems in the pharmaceutical sector. T&T systems have transformed product handling procedures without compromising product quality up till it is dispensed over the years by merging supply chain operations and technology utilization.
A Tokyo-based firm estimated in early 2022 that global innovative pharmaceutical companies suffer a loss of $40 billion annually as a result of counterfeiting. Thus, T&T’s effectiveness results in seamless product management and risk reduction related to falsification and counterfeiting.
Supply Chain Product Visibility Improvement
While tracing procedures are used to identify any problems in the supply chain process, tracking components ensure that the drug product remains intact throughout its ongoing existence. T&T components include 2D printers, labeling equipment, 360-degree cameras, and bundling machines. Together, these components enable end-to-end supply chain visibility up until the point of dispensing. T&T has been forced to further consider serialization as a means of streamlining supply chain operations due to the expansion of e-commerce platforms.
Serialization: A T&T Approach Based on Units
The newest Drug Supply Chain Security Act (DSCSA) mandated by the USFDA and the Falsified Medicines Directives (FMD) mandated by the EU in 2019 both call for a product serialization strategy to thoroughly trace the items. In order to serialize a product, it must be marked with radio frequency identification (RFID), barcodes, holograms, and predetermined codes that are universally unique. In a phase-by-phase process, serialization further integrates and ensures tamper-proof product packaging
The process has the following steps.
• Serializing the information on the drug product’s identifiers using item-level coding
• Bundle coding: serialising supplementary packaging with information about the product’s identity.
Palletization, the process of affixing the cargo pallet with serialised information
• Integrative approach to product lifecycle management leveraging server monitoring
T&T and serialisation obstacles
The supply chain for pharmaceutical businesses will need to be T&T compliant due to the phase-II DSCSA enforcement in November 2023. These technological advancements provide certain challenges for services associated to pharmaceutical packaging and artwork for drug tracking. The difficulties include:
• Delay in coordinating packaging laws among developing countries
• Labeling restrictions to add T&T components in addition to the required labelling contents
• The relative nature of supply chain service providers serving a variety of pharmaceutical enterprises with corresponding IT resources
• A pricey choice made by mid- and small-sized businesses to put up T&T systems and personnel
Pharma T&T and Serialization implementation
By combining the patient-centric market with item-centric serialisation, data management, end-user acceptance, and product traceability can be achieved. The purposes of T&T are highlighted by the following:
• Full product visibility
• Tracking any pharmacovigilance signal management procedures should be simple.
• Enabling machine-to-machine communication, which minimises the need for human intervention
• Database management system with the ability to track and archive products throughout their lifecycles
The serialisation strategy of T&T can be a crucial enabler in unifying packaging and supply chain processes around the world, in accordance with the DSCSA and FMD objectives as well as the demonstrated compliance of international pharmaceutical businesses. Additionally, it can reduce the likelihood of illegal drug use, drug fraud, and drug counterfeiting. The firms will be guided by a specialist with techno-management expertise in tackling such imperatives as Regulatory demands. Check now to learn more about Maven’s innovative Regulatory solutions.
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