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A complex and evolving set of regulations challenges drug manufacturers to understand and implement serialization requirements.
This year, Federal Drug Supply Chain Security Act (DSCSA) drug traceability requirements become mandatory. The new DSCSA requirements will be implemented in three phases over a 10-year period. Phase one, which started on Jan. 1, 2015 and will be in effect until December 2022, requires the exchange of “chain-of-ownership data.” Beginning in November 2017, the second phase will require that “pharmaceutical products be marked with a national drug code, serial number, lot number, and expiration date in machine-readable and human-readable form.” The final phase of the DSCSA requirements, starting in 2023, will require trading partners to share all data necessary to track serialized items to the product’s origin (1).
In 2015, members of the pharmaceutical industry are implementing new equipment and systems and planning for future DSCSA deadlines. Pharmaceutical Technology spoke with Jean-Pierre Allard, global serialization program manager at Optel Vision; Chris Flori, vice-president of business innovation at ASD Healthcare, a part of AmerisourceBergen; and Tim Kearns, pharmaceutical and medical devices manager at Videojet, about the most important aspects of the 2015 and 2017 deadlines, what to consider when planning for the 2023 deadline, and what can be expected when using a cloud-based tracking system to facilitate serialization.
Implementing 2015 and 2017 deadlinesPharmTech: From your perspective, what are the most important aspects to consider when implementing equipment and systems for compliance with DSCSA 2015 and 2017 deadlines?
Allard (Optel Vision): One of the most important aspects to consider is to maintain maximum overall equipment effectiveness. Adding inspection and tracking equipment on a line can drop the line efficiency and affect the company profits and throughput. Floor space required by new equipment is also difficult to manage on the production line. Solution providers are challenged to offer small systems to fit on customers’ lines. Another aspect to consider when implementing printing equipment is the fact that they are subject to vibrations from adjacent machines. For example, instead of embossing the lot and expiration on cartons, one needs to add a data matrix, which can’t be embossed. Thus, the carton serialization requires the integration of printing and inspection systems on existing lines, but as the printing is done in a linear fashion as the carton moves in front of the print head, the surrounding vibrations of a cartoner machine can deteriorate the print quality. This problem leads most solution providers to provide a separate and dedicated machine for carton printing. Overall, floor space and line efficiency are crucial.
Flori (AmerisourceBergen): When weighing the options available to meet the needs of manufacturers and providers, decisions should be based on what will be best for your patients and your business. From the distributor’s perspective, a key question for any equipment or system is: How can the granular data being collected be used efficiently to identify trends in treatment and adherence and to improve patient safety? The implementation of DSCSA can be seen as an opportunity to continue to focus on patient safety, both upstream with manufacturers and downstream with providers.
Kearns (Videojet): In general, meeting the DSCSA requirements is like a jigsaw puzzle. Make sure you have a plan, build the framework, connect the pieces that fit early in the process, don’t hesitate to solicit help, and of course, make sure you use the right pieces. Specifically, identify a team and formulate a plan, find the right equipment (e.g., high resolution, serialization-ready printers) and implement early. Be sure to work with partner companies with open communication.
Preparing for the 2023 deadlinesPharmTech: What do companies need to consider now, when installing equipment and systems, to plan ahead for future compliance with final DSCSA 2023 deadlines for item-level electronic tracking?
Allard (Optel Vision): The main additions in 2023 are aggregation recording at the packaging line and the rework and shipping events captured in the warehouse. In order to comply with track-and-trace requirements, not only must the item level be serialized, it must be associated with its parent shipper case serial number and then up to the pallet serial number. We estimate that currently 50% of our customers will decide to go ahead with the complete compliance 2023 deadline. The reason is simple: going through a single-phase approach [adopting new equipment all at one time] provides savings of up to 25% (direct and indirect costs). Each time the equipment is changed, the packaging line can’t operate for close to two weeks to install and run all the validation tests. During this period of time, as the line is not packaging, there is an indirect cost for the manufacturer, which is a loss of profit. In terms of equipment, this means to equip the packaging line with cameras and controlled printers at the bundle, case, and possibly pallet stations. Concerning warehouse management, when implementing improvements, considerations should be made to the impacts of new serialization for the following use cases: rework, de-aggregation, heterogeneous packing, shipment, and returns.
Flori (AmerisourceBergen): When making decisions today, companies need to plan for the best return on the investment in the future. Flexible, interoperable, and cloud-based systems are best positioned to remain impactful and relevant throughout the transition and into business as usual. While two-dimensional barcodes are the mandated format for product identifiers, radio-frequency identification technology can still be leveraged to obtain key benefits. One would need to create a link between the data components, and then through the cloud, there would be ability to communicate with other systems and the option to view data as needed.
Kearns (Videojet): Companies must implement line-level solutions that are prepared for aggregation, set standard processes for rework, define responsibilities, and identify and address challenges early. In the early stages, it’s important for the company to define other aspects they may be trying to accomplish. For instance, besides identifying the appropriate code and code location, companies should develop an aggregation process so a plan can be started. Also, they should consider all potential products that may run on a particular line. For example, if products will be exported, do they need to plan for adherence to other countries’ regulations?
Cloud-based trackingPharmTech: How does the use of cloud-based track and trace facilitate serialization? What are the concerns with the use of a cloud-based system and how can these be addressed?
Allard (Optel Vision): The main advantages are a faster implementation and the ‘full sub-contracting’ aspect (as the plant’s information technology department would have fewer responsibilities). The cloud also allows easier servicing and pre-installation testing for the packaging-line serialization solution provider. Security is the main concern, but it is becoming less of a concern because the cloud solution can be as secure as, or even more secure than, a conventional on-premise installation.
Flori (AmerisourceBergen): Today’s technology captures granular data in huge volumes that must be stored appropriately while still being accessible. The cloud is an excellent option for secure storage of the data, regardless of the amount. A common concern is understanding what happens if a system goes offline and more specifically, that while offline, the data won’t be captured. Before deciding on a system, ensure it is able to capture data while offline and self-heal when back online.
GS1 US, “Implementation Guideline: Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes, R1.1” (GS1 US, Sept. 14, 2014), pp. 8, 12-14.
Article DetailsPharmaceutical Technology
Vol. 39, No. 5
Citation: When referring to this article, please cite it as A. Roberts, “Planning for the Future of Serialization,” Pharmaceutical Technology39 (5) 2015.