Ensuring Patient Safety through Pharmaceutical Traceability
Data Standardization for Product Identification
One of the key pillars of any traceability system is having a common data standard for uniquely identifying each product instance. In the pharmaceutical supply chain, this often takes the form of a serialization or aggregation level used to print a unique identifier, such as a serial number, on the packaging. To enable pharmaceutical traceability across different systems, it is important that all supply chain partners utilize the same data format for product identification. Standardizing things like identifier length, symbologies used for barcodes or RFID tags, and data elements included helps break down data silos and allows seamless communication of traceability data between manufacturers, wholesalers, pharmacies, and other stakeholders. Harmonizing identification practices is a prerequisite for implementing end-to-end traceability across global and multi-partner supply networks.
Visibility into Movement Histories
Once a consistent identification scheme is established, the next priority is capturing Pharmaceutical Traceability events and building comprehensive product histories. Transporting units from one location to another requires recording transfer data like shipping dates, recipient information, and chain of custody details. Integrating tracking technologies into physical distribution helps automate history collection. For example, applying RFID or network-connected sensor tags enables capturing transit data like temperature, vibrations, and open/closed statuses without manual intervention. Aggregating event logs from each supply chain partner provides a single, chain-of-block chain view into a product's movement from creation to patient dispensation. Pharmaceutical companies can use history information to monitor environmental conditions, trace back potential quality issues, and more accurately recall impacted batches if needed.
Detection and Resolution of Supply Chain Disruptions
With end-to-end visibility and history collection in place, traceability systems support intelligently detecting and resolving various supply chain disruptions. Events like product diversions, counterfeits, or excursions outside controlled storage temperatures can be automatically flagged based on traceability data. Sophisticated tracking and tracing solutions also facilitate quarantining and investigating anomalous product batches to determine appropriate corrective actions. For example, if a shipment container is involved in a traffic accident, the system could detect potential product damage and generate notifications to trading partners advising further examination. Pharmaceutical traceability data is also instrumental in executing targeted recalls of affected products instead of broad blanket recalls that impact unwarranted inventory. The ability to pinpoint supply chain issues and orchestrate data-driven responses increases patient safety.
Ensuring Pedigree Integrity
Complete traceability from source provides pedigree integrity verification capabilities throughout the extended pharmaceutical supply chain. Comparing recorded traceability events against physical inspections validates handling compliance and shipment documentation accuracy. Line clearance procedures involve checking unique identifiers, expiration dates, batch numbers and other attributes match what was approved for distribution. Any deviations can initiate further investigation into potential counterfeits, product diversion, or documentation/packaging inaccuracies. Line clearance acts as a control process to help prevent illegally sourced pharmaceuticals from entering legitimate supply networks. It reduces opportunities for falsified drugs to infiltrate distribution channels where they may unintentionally be administered to patients rather than being intercepted. Overall pedigree integrity mechanisms strengthen protection around critical medications.
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