Markirovka: This word means ‘marking’ in English. There are defined marking rules for traceability systems in many different industries of Russia. Маркировка.

CRPT: This acronym is derived from the first letters of the Advanced Technology Development Center written in the Russian language. We can define it as the implementer company that prepares traceability systems for Russian pharmaceutical projects. ЦРПТ – Центр развития перспективных технологий.

Chestny ZNAK: It is defined as the national Track and Trace software formed by CRPT. It includes all the industries in which traceability systems are being considered to be implemented. честныйзнак.

MDLP: It is a system that enables the traceability of pharma mobility. Every shareholder in the Russian pharma industry has to notify all their medicine mobilities of this system. мониторинг движения лекарственных препаратов

OMS (Order Management Station): This is a system that manages serial numbers and crypto codes that will be used for pharma serialization. You need to pay 0,5 Ruble to CRPT organization for each code which will be taken from the system.СТАНЦИЯ УПРАВЛЕНИЯ ЗАКАЗАМИ.

Russian Crypto Code : Verification Code: A Crypto Code or a verification Code term has been defined for CRPT Markirovka. This Crypto Code which must be implemented within each 2D code as 44 or 88 numerical digits is data supplied by CRPT. The Crypto code is written into the 2D during the print. This data is associated with each serialization number within the OSM system. Код проверки.

The Serialization Of Pharmaceuticals Through Pharma Crypto Code

The track and trace software system which will be implemented for pharma The traceability software system which will be implemented for pharma serialization in Russia is following the GS1 standard. In this respect, this application is similar to the pharmaceutical track and trace software systems determined by other authorities in the world. However, Markirovka keeps a special code for the pharma serialization that will be used on products in Russia.

Some of the technological challenges that have been met in the long-Russain Crypto code are the following.

By adding the 44 numeric digits option, some of the technological challenges for pharma serialization which we mentioned above have been eliminated. Currently, there are two definitions called long verification code and short verification. The pharma crypto code is being provided to the pharmaceutical manufacturers by OMS and it is supposed to be used within 180 days. This is an important issue that should be emphasized, because, an amount of money needs to be paid for each of the pharma crypto codes. The average cost of the 10000 code is 70 €.

The data in the DataMatrix code that complies with GS1 standards, which is preferred for Markirovka in Russia is as follows.

Pharma serialization which is compliant with Markirovka can be implemented through a TIJ and cost-effective camera in case 44-digit Russian pharma crypto code is used and optional spaces are not filled in 2D code. The whole Markirovka process can be defined through a cost-effective camera selection within the aggregation.

Aggregation Process

The aggregation which will be implemented in traceability systems for all the products in Russia is compulsory. After the implementation of aggregation, the SSCC method by GS1 is being used for the serialization of all the products. From this aspect, the Russian system is not very different from the aggregation system of the other countries. So, cartons precede cases in the Russian pharmaceutical industry.

However, while aggregation is implemented, there have been some challenges during the bulk reading process of data matrix codes defined by Markirovka rules.

Because pharma crypto codes cause data density, the decoding rate of systems that have been designed for standard applications is not at the desired levels.

VISIOTT TPS has figured out the Markirovka requirements at the aggregation stations for the Russian pharma traceability systems, designed the camera, lighting and hardware components in compliance with these. Furthermore, VISIOTT TPS can manage aggregation by implementing an integration into your current case packer stations.

Connection With MDLP

MDLP is the component of the national Chestny ZNAK project which has been designed for the mobility of medicines. It is specifically prepared for the pharmaceutical industries in Russia. It has a more complex infrastructure than the regulations of other countries in which the data is reported to the health authorities. To give an example, it is mandatory that each notification to the MDLP system be signed.

MDLP accommodates all the terms to trace the lifecycle of each pharmaceutical product. These terms might be listed under sub headings as follows.

1. The notification of the pharmaceutical products to the system which are produced within Russia.
2. The notification of the pharmaceutical products to the system which are imported to Russia.
3. The mobility of sales and storage
4. Extirpation and recalling.
5. Relabeling
6. Aggregation and transformation operations
7. Operation cancellations

MDLP accommodates 52 notifications under these headings. If you want to excess in more detail, please, click the link.

Integration With the Third Party Softwares

There are many ERP and MES systems for production, sales and storage management in Russian pharma industry. Your integration with the ERP / MES system that you have used in order to keep up with the digital transformation and establish right traceability systems is the best solution.

We advise you to integrate with the ERP and MES system with the synchronization headings described below.

VISIOTT TPS Level 3 Plant Manager software manages to use the various data sets in operations such as master data, work order and order information through its integration with many systems.

Author: Emre ÖZDEN
LinkedIn Article