Russia's New Track & Trace Regulations
Know How

Russia's New Track & Trace Regulations

Know How

New Challenges for Pharmaceutical Manufacturers and how to Solve Them

The new Russian rules for serialization and aggregation are out, and the deadlines have been set. There is not much time between now and the initial deadline for manufacturers to bring themselves into compliance – and even less time to begin addressing the challenges of these new requirements. We will focus specifically on the challenges for the product packaging site – the moment where the product is assigned its serial number and cryptographic code.

The Basics

Like all other serialization requirements, the core requirement is the same: each individually packaged unit needs to have a serial number assigned to it, which is then recorded and transmitted to the Russian government. The difference is one of complexity – while the European FMD or the US DSCSA regulations have similar requirements, there are two differences that complicate matters for manufacturers:

  1. The requirement for printing a cryptographic code onto each secondary package.
  2. A much more thorough recording of a package's movement through the supply chain.

Packaging Challenges

The second difference is less of a concern for packaging sites – they fall under the responsibility of Level 4 and Level 5 systems, and include a whopping 36 compliance events that need to be recorded, a far cry from the EU FMD's 7 – but the addition of a crypto code to the product packaging poses a significant set of challenges. Namely:

  1. Crypto codes need to be requested from a webservice (if the packaging step occurs outside the Russian Federation) or from encryption hardware (if packaging occurs inside the Russian Federation).
  2. Crypto codes must be printed on each secondary package. The codes are 44 characters long, and the included crypto key is an additional 4 characters long. This doubles the required capacity of the data matrix code
  3. The data matrix code needs to be readable by inspection and aggregation cameras.
  4. The system must report the use of the Crypto Code to a centralized information database.

These are more than the usual requirements for serialization, but meeting them is a simple enough matter requiring only a few alterations to existing processes. For the most part, existing production lines will need to make some changes – but the nature of those changes depends on the manufacturer's decision.

Requesting and Handling Crypto Codes

This is the first new step in the serialization process, which will require the level 2 and level 3 software to be upgraded. Essentially, site-level management software will need a connector and workflow added in order to request the Crypto Codes and keys from the Russian-run webservice. It is also possible that this step would be handled by a Level 5 cloud provider, in which case the level 2 and 3 software would need to have a different workflow. Manufacturers should check with their level 5 cloud providers to see which option they will need to implement. These codes must be marked as used or discarded to the Russian webservice no more than 180 days after being retrieved from the server, so it is important that manufacturers implement a method for tracking when a code is about to expire and purge their database of codes accordingly. We suggest coordinating with your level 3 and 4 software providers to find the best solution for keeping track of this.

Printing and Verifying the Crypto Code

The printing of the serialization information is, perhaps, the largest challenge. In essence, the addition of the crypto code increases the amount of data that needs to be encoded into the data matrix code. Normally, the required information can be contained in a 22x22 module format – this includes mandatory serialization information along with optional information such as lot code and expiration date. In order to add the new required crypto code, the format needs to increase to 36x36 modules. Fortunately, existing print heads should be more than capable of printing at this increased size. The increase in the physical size of the code is not insignificant, but most standard pharmaceutical packaging should be able to accommodate the larger code with no major need for adjustment.

Aggregating Crypto Codes

As the Russian regulations mandate aggregation of all codes, it is necessary to have a high resolution camera or smart camera capable of reading and aggregating the codes together. Most manufacturers are already aggregating, and fortunately, most high resolution cameras should be able to easily adapt to a larger physical code size.  

Reporting Consumed Crypto Codes

As with requesting the codes, the specific process of contacting the Russian central information system can either involve the level 2 or 3 system reporting the crypto code use directly to the Russian service, or it can involve the level 2 or 3 system passing information to the level 4 or level 5 interface, where it is then reported. It depends on the capabilities of the level 4 or 5 interfaces.

How METTLER TOLEDO can Help

To address these challenges, METTLER TOLEDO PCE has developed the necessary software upgrades to our PLM and PSM software to enable either direct communication with the Russian webservice or communication with Level 5 cloud providers, making it easy to obtain the necessary crypto codes. For data export and reporting, we can report back to the Level 5 system, or provide a direct connection to the Russian webservice. For manufacturers with multiple production lines which might not all be producing Russia-bound products, upgrading PSM for Russia does not make it incompatible with lines not producing products for Russian use – meaning only the lines which need crypto code functionality will need to upgrade their versions of PLM.

In addition, we are ready to provide an evaluation of your current printer and camera setup to provide advice on what software and hardware changes (if any) are required. Bear in mind that you will need to talk to your printer provider as well – the final recommendation on printer capabilities should ultimately come from them. We can also provide replacement cameras for any existing METTLER TOLEDO PCE cameras already on your production lines, should it be necessary.

This is all with the usual on-site evaluation, software and IT consultation, and complete project management that you have come to expect from METTLER TOLEDO. Time is of the essence, so get in touch with us to start the evaluation process now! 

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