Münchendorf, August 2026
Serialized identification and tamper-evident packaging fulfil different functions within pharmaceutical traceability and can be combined within one packaging concept
The Drug Supply Chain Security Act (DSCSA) establishes requirements for the identification and electronic tracing of certain prescription drugs in the United States. Package-level serialization provides a standardized means of identifying and verifying individual pharmaceutical packages throughout distribution.
“Serialization alone, however, does not indicate whether a package has been opened or physically altered, which is why manufacturers may combine digital identification with tamper-evident labels or seals. Serialization identifies the package, while the physical security feature shows whether the package has been interfered with,” explains Dave Sandello, Vice President of Securikett Inc. in the US. “These are separate functions, although they can be integrated into the same label.”
Serialization and Tamper Evidence
Serialized labels can carry an individual identifier for each packaging unit and be integrated into existing production and data-management systems. Tamper-evident constructions, depending on packaging format and substrate, can include VOID effects, destructible constructions or other mechanisms that provide visible evidence when a label or seal has been removed, opened or manipulated.
“A serialized code can still remain readable even if the package itself has been manipulated,” says Sandello. “For that reason, digital identification and physical tamper evidence address different aspects of package security.”
Additional Authentication Functions
Where required, serialized and tamper-evident labels can also include overt, covert or machine-readable authentication features, as well as QR codes or other digital identifiers used for product verification and track-and-trace applications.
Scan data can additionally provide information about repeated code use, unusual geographic activity or products appearing outside defined distribution channels.
Combined Packaging Concepts
Serialization, tamper evidence, authentication and track-and-trace serve different purposes within pharmaceutical packaging, but can be combined where manufacturers require several security and identification functions within one packaging component.
