Pharmaceutical Track and Trace Solutions

Currently, coding standards for track and trace come from GS1, who among other things have set forth the formatting for international serial numbers and communication standards for RFID tags. As a global healthcare voting member within GS1, METTLER TOLEDO is active in helping to create further track and trace standards. Learn more from our Print & Verify Webinar Series about "Global Regulatory Compliance for Track & Trace, Featuring GS1."

Each country or regional government body develops regulatory requirements around product labeling. Most regulations follow similar requirements that packaging must be machine and human readable, however there are nuances. For global manufacturers, they must pay attention to the unique labeling requirements as they manufacture products for distribution in different countries. Consider Russia as an example, their legislation requires advanced cryptographic codes which is more complex than the European Falsified Medicines Directive (FMD) or the US Drug Supply Chain and Security Act (DSCSA). Understanding these differences is critical to streamlining production: too little information on the label means non-compliance, fines and negative brand reputation whereas too much information means inefficient packaging processes with unnecessary steps. The ability to modify production processes provides the needed balance between efficiency and the support of compliance.

All METTLER TOLEDO systems support compliance with international traceability regulations. This includes the Falsified Medicine Directive (FMD) in the European Union and the Drug Supply Chain Security Act (DSCSA) in the United States. In addition, we support the additional requirements for the use of cryptographic codes in Russia, along with other pharmaceutical track and trace regulations in countries across the globe. We also work closely to help manufacturers comply with industry requirements, such as the increased push for aggregation in addition to serialization from major drug manufacturers.

With our extensive experience in numerous global customer installs, we have seen numerous challenges during installation of track and trace programs. Through these experiences, we have developed a rigorous process for developing integrated solutions. Each project is handled by our knowledgeable project management team using the following 4-step process:

1. Consultation — At this stage we gain a thorough understanding of customer requirements, including how the solution will fit into the overall production environment, IT infrastructure and inventory management systems.
2. Project Definition — We create the specification of the required solution and develop a detailed implementation project plan including integration into the production line.
3. Implementation Services — We install the hardware and integrate the solution into the customer's data management network to support the regulatory and compliance needs.
4. Operations Support — Comprehensive service and support options are available to help train staff or provide regular maintenance for minimal interruptions to production.