TraceLink Simplifies Crypto Code Management for Russia Compliance
Pharmaceutical manufacturers that produce or distribute medicines within Russia need to comply with the most complex serialization regulations in the industry, including government order #2963-p, which requires that cryptographic codes are added to the 2D data matrix barcode on package labels along with the standard Global Trade Item Number (GTIN) and serial numbers. Generating and managing these codes can create considerable challenges for your business, but TraceLink's new Russia Crypto Code app uses a single integration point to simplify and manage these requirements for you.
Crypto code requirements, which continue to evolve, were created by the Russian Federation as a way for pharmacies in remote areas of Russia to verify serial numbers when they do not have consistent access to the internet. The crypto code regulation affects any product distributed within Russia, whether it is packaged domestically or internationally.
Read on to learn about the current state of Russia cryptographic codes; the problems created by the requirements; and how our Russia Crypto Code app can simplify your approach.
Why Are Crypto Requirements So Complex?
Russian Federation regulations require that packagers request and receive crypto codes from the CRPT, a public-private organization in Russia. The packagers use the GTIN and serial number of the product to submit a request to the CRPT to create a crypto key of 4 digits and a crypto code of 88 digits that need to be placed on the 2D barcode of the package.
Once the crypto codes have been printed on the barcode of the package, they must then be purged from the manufacturer's internal system per the Russian Federation electronic record keeping regulations (21 CFR Part 11 in the USA and Annex 11 in the EU). The only system that can retain a final copy of the crypto codes is the IS MDLP, which is the Russian federal repository and tracking system for serialization and traceability regulations.
How Crypto Codes are Generated
There are two ways that a pharmaceutical packaging company can access, create, and assign crypto codes:
- Product serialized outside of Russia: Packagers will utilize a web service provided by the CRPT to request and receive crypto codes.
- Product serialized inside of Russia: Packagers will request and receive crypto codes from a physical black box that is provided by CRPT and installed at the packaging location.
Managing Crypto Code Requirements Creates Operational Challenges
Crypto code regulations introduce complexities for companies large and small alike. Even in the simplest manufacturing and packaging environment, the company is responsible for obtaining, maintaining, and purging these codes. For large multinational companies with a variety of packaging locations, it will be even more challenging. They need to integrate crypto code management across multiple internal packaging line Level 3 (L3) systems and Contract Manufacturing Organization (CMO) L3 systems.
If manufacturing companies with multiple L3s managed crypto codes on their own, they would need to communicate with all of their L3 systems individually to make sure each one is requesting and receiving crypto codes through the CRPT. Additionally, the L3 system at each of the packaging locations would need to connect externally to the CRPT and validate that connection, which requires complex technology changes to their systems.
How TraceLink Solves Your Crypto Code Management Problem
TraceLink's Russia Crypto Code app provides a single integration point to the CRPT web service for all customers and their CMO sites that package Russian product, effectively managing this process for them. The app removes the need for the L3/packager locations to connect externally to the CRPT and validate that connection. Instead, each L3 will create a second interface to ensure that the validated, existing integrations with the L3 remain untouched and reduce implementation complexity and additional validation work.
The Russia Crypto Code app takes the GTIN and serial number that is sent from the L3, makes the request into the CRPT web service, and receives the crypto code to return to the packager for the 2D barcode. Once the crypto codes are applied to the 2D barcode, TraceLink's Russia Crypto Code app purges the codes from the system, as required by the law, but maintains an audit trail to meet 21 CFR Part 11 and Annex 11 compliance requirements.
Take the burden of complex Russia compliance requirements off your operations by choosing TraceLink's Russia Crypto Code app for simplified crypto code management. Our app is purpose-built to manage, generate, send, and purge crypto codes from L3 systems, and will continue to keep pace with the regulations as they evolve over the coming weeks and months. Contact us to learn more about Russia crypto code management.