Drug repackagers face unique challenges under the Drug Quality and Security Act (DQSA), driven by their distinctive position in the pharmaceutical supply chain. One major US drug repackager needed a solution with a wide breadth of features and comprehensive configurability to get in compliance with DQSA so they reached out to Systech for assistance.
Serialization forms the new basis for the ongoing effort to secure the supply chain—most significantly the pharmaceutical supply chain, but also increasingly in other sectors. However, it is only the foundation on which other technologies are built to add this sought-after security. Serialization goes far beyond placing a number on a box. These associated technologies, and the terms used to describe them, are explained here.
The opioid crisis in the United States has been described as an epidemic requiring urgent action on the part of government, law enforcement, health advocates and other stakeholders. A substantial portion of overdose deaths result from opioids produced by reputable manufacturers for legitimate medical purposes that have been redirected to illegitimate use. This transfer of a legal substance to illegitimate or illicit use is known as diversion, and represents a major challenge in the...
Aggregation is a technique used in conjunction with serialization that establishes and records the relationship between a serialized object and its container, which also is serialized. Aggregation is most frequently used in the supply chain to place smaller packaging units inside of larger ones, such as cartons packed into cases and cases onto pallets. The aggregation relationship directly mirrors the physical packing of the objects into their container.
Serialization is the application of a globally unique serial number to supply-chain objects, particularly retail units. Successful serialization, particularly of mass-produced items, requires the integration of multiple systems, including enterprise software, printer or tagging technologies, reader systems, and production machinery, to apply and verify unique serial numbers.