Leading Global Serialization Programs
Many nations have enacted serialization regulationsĀ to combat counterfeit products and diversions ofĀ legitimate pharmaceutical products, and those thatĀ have not are planning to do so. Despite the standardsĀ outlined by GS1, these regulations may haveĀ varying requirements. For instance, while unique serial numbers are required on the saleable unitĀ packages in all countries, the United States stronglyĀ 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 IdentificationĀ Numbers (GTINs), but Brazil requires them to beĀ unique across all GTINs. Some countries require Ā randomization of unit saleable package serial numbers, though these requirements are not standardized.Ā Furthermore, the national government ofĀ China provides serial numbers to manufacturers.Ā Pharmaceutical companies that operate or distributeĀ their products on a global scale must be aware ofĀ these differences ā along with the deadlines forĀ such requirements.
HARDWARE Ā & SOFTWARE VENDORS – Vendors providing essentialĀ computer software &Ā hardware for serializingĀ packaging lines (L1, L2,Ā L3 systems) are underĀ intense pressure to meetĀ demand. As such, manyĀ are rapidly expanding theirĀ workforces; however, newĀ employees are often lessĀ efficient, which may impactĀ lead and response times. Equipment fabrication andĀ delivery lead times areĀ also increasing, often by between 50 and 100%.
PARTNERĀ COMPLIANCEĀ REQUIREMENTS –Ā The US deadline for serializationĀ by all manufacturers is November 27, 2017. Many companies have begun implementing serializationĀ solutions. Some tradingĀ partners, including theĀ largest pharmaceuticalĀ distributors, are requiringĀ serialization with aggregationĀ well in advance of theĀ regulatory deadline to optimizeĀ business efficiency.Ā More will do so as theĀ deadline approaches.
LABELING &Ā PACKAGINGĀ DESIGN –Ā Artwork considerations mustĀ be addressed in advanceĀ of, and throughout, equipmentĀ installations. CurrentĀ unit saleable packagingĀ designs may not accommodateĀ the 2D or humanĀ readable serial numbers.Ā Redesigns typically includeĀ revising layouts, font sizes,Ā and colors to ensure sufficientĀ contrast and clarityĀ for scanning.
PRODUCTIONĀ FACILITIES &Ā CAPABILITIES –Ā Since most packagingĀ 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,Ā packaging lines may not beĀ available at optimal timesĀ for serialization installationsĀ and testing.
SERIALIZATIONĀ RESOURCES – Ā Ensuring that the appropriateĀ resources are availableĀ to lead, manage and implementĀ serialization initiativesĀ is critical. While leadership support is vital to the successĀ of any such project, globalĀ serialization will also requireĀ input and collaboration fromĀ departments across the organization.
To learn more aboutĀ Leading Global Serialization Programs, click through to the PDF below.
