Regulations requiring drug packaging to be serialized are not only in the pipeline, but actually becoming a reality in many places. In the EU serialization of prescription drugs is compulsory by 9th of February 2019 – Delegated Regulation (EU) 2016/161. The Drug Supply Chain Security Act (DSCSA) in the USA will make serialization mandatory at the end of 2017 and require seamless track & trace procedures for medicines to be implemented by 2023.
Find out how to get ready for serialization and dealing with international track & trace processes.
Click on a country to obtain detailed information on the applicable regulations and deadlines.
If you are exporting medicines to several different regions or providing packaging or printing services to various manufacturers, serialization can soon become a complex challenge because only unique serial numbers are allowed.
In addition, the issued serial numbers must be correctly recorded, saved and reported to the relevant authorities’ databases.
If you operate multiple production and packaging lines and produce at different sites, you will quickly encounter feasibility problems without the assistance of centralized serialization software.
MEDTRACKER is a centralized software solution for controlling and monitoring serialization and track & trace processes. It is designed for implementation at line, site or enterprise level. MEDTRACKER is capable of generating and managing unique serial numbers, and reliably distributing the codes to any number of machines or units.
Thanks to its modular software architecture, MEDTRACKER can be adapted to suit the requirements of any individual unit or line and be retrofitted with additional functionality at any time with minimal input. MEDTRACKER can also be connected to numerous conventional ERP systems.
The menu item timeline contains information on planning a serialization project and calculating the implementation time correctly.
Further information on the options and benefits provided by MEDTRACKER is available under the menu item system solution.
Among the cited concerns and reservations are the unresolved question of integrating ERP systems, simultaneous production management encompassing multiple lines, maintaining production capacity, and compatibility with existing machinery.
Considering it can take quite a while for planning and implementing such a complex project, very little time remains before the imminent introduction of regulations in the EU and the USA.
Each affected enterprise must plan and act well in advance if it wishes to be in a position to serialize drugs by the cut-off date. A lot of time can elapse from engaging in initial deliberations, performing process analyses, and identifying suppliers, to converting and commissioning machinery, and training staff.
The recommended first step entails assembling an inter-disciplinary project team, appointing a project leader, and establishing an information management platform. Serialization is a subject that concerns numerous departments from production and packaging design, to purchasing, quality, logistics and IT.
Before the search for a suitable supplier is initiated, sufficient time should be set aside for thoroughly analyzing the processes that exist inside the company. The outcomes will make it easier to instruct prospective software and hardware suppliers, and identify the best partner. Given that unforeseen challenges are likely to arise in any pilot project, some time should be reserved for contingencies as well. Consideration must also be given to the suppliers’ lead times.
Bottlenecks can occur, for example, if careful plans are made and implemented for the production machinery and software, but not the IT hardware. Alongside other factors, audit-proof serialization depends on the availability of absolutely fail-safe and resilient servers.
External business partners, such as packaging suppliers and service providers, as well as wholesalers, should also be integrated in the project because they may need to work with your serialized data as well.
The amount of time to be scheduled for the individual phases depends to a large extent on the scope of the project, but in most cases more than a year is likely to be required. Implementing a serialization project – especially in the case of pilot lines – can sometimes take as long as 15 to 24 months.
Once a serialization project has been successfully completed on a pilot line, further lines can be set up much more quickly, especially if uniform standards have been established inside the company.
Introducing serialization and track & trace presents not only a challenge, but also a major opportunity to optimize the value chain. Having examined every process stage in detail, the implementing enterprise is well equipped to resolve problems and enhance efficiency.
We are a leading provider of sophisticated individualization, serialization and track & trace solutions, which efficiently and seamlessly monitor product movements, securely verify authenticity, and reliably protect against counterfeiters.
Specifically for the pharmaceutical industry we offer system solutions to ensure the compliant, reliable, fast and cost-efficient application of unique security features to individual and mass products. Our solutions consistently bring together the latest machine and printing technologies with intelligent and modular software architecture providing full process safety.
Depending on country of destination and production volumes, we offer a variety of customizable solutions for implementing serialization and track & trace processes.
Atlantic Zeiser develops and produces all the core technologies in-house. You too can benefit from our unique expertise, encompassing hardware, software and ink. These are the tools for building compelling one-stop solutions.
The pre-coding of flat cardboard cuts in large quantities with high-performance printing systems, such as the DIGILINE Single, is the recommended approach for exports to the Chinese market, where expiry and batch information is not included in the coding. This makes it all the more important to manage the pool of serial numbers provided and used by the authorities.
The pre-coding approach makes sense for large production quantities in other markets if multiple production lines are operating just-in-time and simultaneously.
For the EU market, the USA, Brazil and other nations, the late-stage coding of packed and closed folding boxes is recommended because expiry and batch information is included in the codes for these countries. Compact units are utilized for this purpose, such as our MEDILINE T&T, which can be integrated in existing packaging lines to print and verify filled folding boxes, and reject non-compliant items as necessary – all within a very small footprint.
Where space is at a premium, the components needed for serialization – printer and camera – can be installed in the plant’s case packers. This work is generally performed in collaboration with the machine manufacturer.
For the serialization of pharmaceutical plastic bottles which are very common in the US instead of folding boxes self-adhesive flat labels are the first choice.
DIGILINE Label is an inline printing system for the fast and efficient serialization of flat labels in high and durable quality. The labels are directly fed to a label applicator while the necessary data for serialization is provided by the MEDTRACKER database. In a second step the serialized items are verified by an inspection camera later in the packaging line and can be reported back to the database.
Besides of HDPE bottles, labels are also suitable for any primary and secondary packaging that can due to their form or material not be printed directly inline.
In various markets, including China, both serialization and track & trace processes are compulsory for pharmaceuticals. During the packaging operation, the codes applied to individual packs must be assigned to bundles, cases and pallets by way of hierarchies (parent-child relationship).
For larger production quantities, the components required for this purpose – camera, label printer and applicator – can be integrated in automatic case packers. When working with smaller batches and frequently changing jobs, a manual aggregating station with integrated code scanner, such as the MEDILINE CodeCollectM, is a great choice.
Given the inevitability of manual reprocessing that is associated with fully automatic packaging lines, we offer solutions to satisfy this need as well. They can also be used for both repackaging operations in the warehouse and dealing with returns.
Even though the aggregation of individual packs is not yet mandatory in some regions, it is a process that can generate significant value, typically for those seeking to optimize logistics.
Thanks to MEDTRACKER, the serialization and track & trace processes described on these pages can be controlled and monitored centrally across multiple lines and sites.
MEDTRACKER encompasses all the current and forthcoming regulations and principles governing coding and serialization. Thanks to its modular software architecture, new requirements can be incorporated subsequently at any time.
When you embark on the search for a suitable supplier, asking a few key questions can prove useful
Atlantic Zeiser can answer “yes” to all these questions. As a highly skilled supplier of serialization and track & trace systems, we offer you the best possible solution and perfect project implementation.