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Russia_pharmaceutical

Russian Crypto Code for Pharma Industry

In this article, We will try to clarify the new pharma serialization project which will be implemented in Russia after July the 1th, 2020.   We think that we need to explain this project in 4 sections. 

  1. Track and Trace Serialization for Markirovka
  2. The standard aggregation process
  3. The connection to MDLP (How to connect MDLP?
  4. Integration with the third party softwares

Before explaining all these processes, since I believe that some terms should be well understood,  I advise you to take a look at the glossary down.

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 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.

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

OMS (Order Management Station) : This is a system which manages serial numbers and crypto-codes which 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 digit is a 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 Medicines Through Markirovka

The track and trace software system which will be implemented for pharma seriziliation 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. 

  1. The challenges in providing code quality with conventional printing method.
  2. Spending extra (excessive )time to decode the codes and measure its quality.
  3. Needing a costly and high resolution camera for pharma serialization and aggregation

By adding 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 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 emphasised, because, an amount of money needs to be paid for each of the crypto codes. The average cost of the 10000 code is 70  €.

The data in the DataMatrix code that is in compliance 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 crypto code is used and optional spaces are not filled in 2D code. The whole Markirovka process is able to be defined through a cost-effective camera selection within the aggregation.

Crypto Code Table

Wrong designs in hardware is a factor that decreases serialization efficiency. However, VISIOTT has protected the efficiency of Markirovka Carton Serialization Stations by developing innovative designs.

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 precedes cases in 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 crypto codes cause data density,  the decoding rate of systems which have been designed for standard applications are not at the desired levels. 

Crypto Code Sample

VISIOTT 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 is able to manage aggregation by implementing an integration into your current case packer stations.

Connection With MDLP

MDLP is the component of the national Chestnyy 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. 

VISIOTT Level3 Plant Manager is able to implement all the notifications that you are obliged to do the MDLP system. In order to configure these notifications according to your product, sale and storage operations, please contact us.

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.

  • Master Data
  • Work Order
  • Ordering Information

VISIOTT Level3 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

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