Many nations have enacted serialization regulations to combat counterfeit products and diversions of legitimate pharmaceutical products, and those that have not are planning to do so. Despite the standards outlined by GS1, these regulations may have varying requirements. For instance, while unique serial numbers are required on the saleable unit packages in all countries, the United States strongly implies the need for aggregation. Robust global serialization programs are critical to meet these mandates.
Most countries allow unit saleable package serial numbers to be combined with product Global Trade Identification Numbers (GTINs), but Brazil requires them to be unique across all GTINs. Some countries require randomization of unit saleable package serial numbers, though these requirements are not standardized. Furthermore, the national government of China provides serial numbers to manufacturers. Pharmaceutical companies that operate or distribute their products on a global scale must be aware of these differences – along with the deadlines for such requirements.
HARDWARE & SOFTWARE VENDORS – Vendors providing essential computer software & hardware for serializing packaging lines (L1, L2, L3 systems) are under intense pressure to meet demand. As such, many are rapidly expanding their workforces; however, new employees are often less efficient, which may impact lead and response times. Equipment fabrication and delivery lead times are also increasing, often by between 50 and 100%.
PARTNER COMPLIANCE REQUIREMENTS – The US deadline for serialization by all manufacturers is November 27, 2017. Many companies have begun implementing serialization solutions. Some trading partners, including the largest pharmaceutical distributors, are requiring serialization with aggregation well in advance of the regulatory deadline to optimize business efficiency. More will do so as the deadline approaches.
LABELING & PACKAGING DESIGN – Artwork considerations must be addressed in advance of, and throughout, equipment installations. Current unit saleable packaging designs may not accommodate the 2D or human readable serial numbers. Redesigns typically include revising layouts, font sizes, and colors to ensure sufficient contrast and clarity for scanning.
PRODUCTION FACILITIES & CAPABILITIES – Since most packaging lines were not designed with serialization in mind,installations often require relocating, modifying, or replacing equipment, and perhaps alterations to plant buildings and infrastructure. In addition, to meet demand, packaging lines may not be available at optimal times for serialization installations and testing.
SERIALIZATION RESOURCES – Ensuring that the appropriate resources are available to lead, manage and implement serialization initiatives is critical. While leadership support is vital to the success of any such project, global serialization will also require input and collaboration from departments across the organization.
To learn more about Leading Global Serialization Programs, click through to the PDF below.