Pharmaceutical Track and Trace Solutions | Industry Partner | Security

What are the relevant pharmaceutical track and trace regulations?

Manufacturers undergo intense scrutiny in the development, testing and distribution of pharmaceutical products. It is a natural progression to ensure that the end product is safely delivered into the patients’ hands. As counterfeit operations have ramped up in recent years, there has been a need to develop anti-counterfeit measures in the form of advanced directives by governments and regulatory bodies. While many countries have specific legislation for combating counterfeits, the US and EU have introduced robust regulations to address this issue:

  • Drug Quality and Security Act (HR3204), followed by Title 11: Drug Supply Chain and Security Act (DSCSA), enforced in 2017. Provides specific directives for serialization of the individual salable unit, and went into enforcement in 2019 due to industry demand for additional time to implement processes. There is an anticipated aggregation requirement set to go into effect in 2023.   
  • The EU Falsified Medicines Directive 2011/62, enforced in 2019. As European countries began to adopt their own requirements for serialization, the EU Commission saw a need for unified regulations to make transport and distribution easier.

Are there international standards for track and trace?

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.

Do you have systems that comply with all international track and trace regulations?

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.

How do you go about starting a track and trace program?

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.

Track & Trace Solutions | Serialization and Aggregation Systems

Track & Trace Solutions

Systems and Software for Compliant Serialization and Aggregation

Guide to Track & Trace Technology for use in the Pharmaceutical Industries

Guide to Track & Trace Technology

Building an Effective Program

Understanding Regulations in Medical Device Labeling

Aggregation Solutions for the Traceability of Products – Free Download

Explaining aggregation process in serialization applications

Russia's New Track & Trace Regulations

Russia's New Track & Trace Regulations

New Challenges for Pharmaceutical Manufacturers and how to Solve Them