Basic ITS Concepts

GS1 (GS1 Standards One)

Trade going beyond national boundaries and reaching an international dimension, the increase of fluctuation in product demand, the increase of customer expectations has brought about the need to generate new solutions to boost the efficiency of the supply chain.

In accordance with these changes in trade, in 1974 manufacturers and distributors from 12 countries have participated in the works to constitute a standard fort the identification of the products in Europe; thus in consequence of these works the International Article Numbering (Originally European Article Numbering, which has been changed to International Article Numbering although the abbreviation remains as EAN) Association whose center is located in Brussels was founded in the year 1977.

The basic task of EAN is to develop international standards suitable for every sector which can define products, services, transportation units and inventories in order to provide efficient supply chain management. Local organizations which are members of EAN are obliged to apply and develop international standards in their own regions.

Over time, EAN’s member profile has gone beyond Europe and has spread over the world, thus in 1992 EAN was given the name International. In the 2000s The International EAN Association’s basic goal has gone beyond simply the creation of definition standard and much greater targets were wet.

In order to fasten and increase the efficiency of the communication among the manufacturers and the customers and to provide tracking of the products within the supply chain, projects like GDSN (Global Data Synchronization Network), RFID (Radio-Frequency Identification) and tracking were developed.  As a result of the fact that EAN International no longer appears as an organization which only creates defining standards its name has been changed at the beginning of 2005 as GS1. Today, GS1 has 101 member organizations representing 103 countries.

In 1988 GS1 Turkey has been founded as “National Goods Numbering Center” within Turkey’s highest ranking representative of the private sector, The Union of Chambers and Commodity Exchanges of Turkey (TOBB) in order to provide the trouble-free recognition and tracking of commercial products that are produced and offered for sale in Turkey in national and international trade and became a member of EAN.

As EAN changed its name to GS1, The “National Goods Numbering Center” changed its name to “GS1 Turkey” in March 2005. GS1 Turkey with 15000 members continues to provide membership of the manufacturers, distributors and supplier companies in Turkey to GS1 system, thus provides their worldwide recognition, ease the applications of these companies and makes issue specific regulations for Turkey to provide support for companies.

(This part of the article has been translated from the original copy retrieved from the GS1 Turkey official website )

DataMatrix

DataMatrix is a symbol constituted by the encoded text and/or number characters which is composed of black and white cells on a square (10x10, 144x144) or rectangular (8x18, 16x48) field.

It’s general data size can change from very few bites to 1556 bites. The codified data is associated with the amount of cells that will be used within the DataMatrix. Even if some cells of the DataMatrix get harmed so that they cannot be read, it is possible to read these with the Error Correction Technique (ECC 200). One DataMatrix symbol can include 2.335 alphanumeric characters. Depending on the coding used, a white cell represents 0 and a black cell is a 1, or vice versa.  Every DataMatrix is composed of two solid adjacent borders in an "L" shape (called the "finder pattern") and two other borders consisting of alternating dark and light "cells" or modules (called the "timing pattern"). DataMatrix symbol sizes vary from 8×8 to 144×144.

DataMatrix codes is able to encode 50 characters in 2-3 mm2, that is readable with only a 20% contrast ration (low contrast). In commercial applications they are able to be scaled and readable as small as 300 micrometers and as large as 1 meter square.

The DataMatrix has an error rate of less than 1 in 10 million characters scanned.  (Retrieved from Wikipedia)

Drug DataMatrix is the general name given to the DataMatrix used on the drug packages in our country. Drug DataMatrixes include four data. These are;

Barcode Number – GTIN (Global Trade Item Number): The maximum 14 digit number which serializes products worldwide.
 

Serial Number – SN: The unique registration number for defined by the manufacturers for each unit/package on the basis of products.

Expiration Date – XD: The last date that the product can safely be used.

Batch Number – BN: Is the registration number that distinguishes a batch from another during its manufacturing. 

“The Regulation on Packaging and Labeling of Humane Pharmaceutical Products” which was published in the 12.08.2005 dated and 25904 numbered official gazette was updated with the 02.02.2008 dated and 26775 numbered “Regulation for the Amendment of the Regulation on Packaging and Labeling of Humane Pharmaceutical Products”. Thus, the barcode applied on to the product packages was removed and it was decided to apply DataMatrix for the serialization of the drug units.

You can access the details of "Guidance on Implementation of Identification and Barcoding of Medicinal Products for Human Use" on the guides web page.

GLN (Global Location Number)

GLN is a 13 digit number given by the barcode authority, GS1 in order to uniquely define a location in a world scale. GLN indicates the legal, functional or physical allocation unit in a workplace environment or an organization.

The location numbers which are called GLN, are used as access keys to reach the identifying information of the locations kept in the databases of the information systems. By using GLN the information related to a location in their database (For example: The legal address of a company, mailing address, shipping address, telephone and fax number, relevant person etc.) can be reached.

GLN usage has also been accepted in Turkey and its usage to identify all stakeholders in the ITS system has been planned. Drug manufacturers, importing companies, reimbursement agencies and pharmaceutical warehouse stakeholders can receive their GLN number to be used in ITS by making an application to TOBB-GS1 Turkey (The Union of Chambers and Commodity Exchanges of Turkey). Pharmacies, hospitals and other drug consuming centers may get their GLN numbers automatically from a field which has been reserved by TOBB for the Ministry of Health after registering to the local health authority.

Web Service

Web services are modular application functions which can be published in web environments, can be searched and found and accessed through calls. With these functions different corporate business processes can be carried out.

In the course of ITS and PTS notifications, web services are used for the communication with stakehokder softwares and data transfers.For more detailed information on ITS and PTS web services you may examine the Guideline on ITS Web Services.

Notification

The transfer of all the transactions of the products beginning with their manufacturing or their importing until they reach their last user made by the stakeholders to the ITS system through web services are called notifications. With these notifications, stakeholders deliver the final satus and ownership information of drug units they have made actions with to ITS.

ITS returns answer notifications  for the notification’s achievement status for every notification and the reason of its failure if failed. The types and contents of notifications are determined in the Pharmaceutical Track and Trace System Operational Manual, while the notification structures are defined in the Guideline on ITS Web Services. Please visit the Guidelines web page for more detailed information on notifications and notification answers.

Transportation Units

Containers or packaging units used for the transportation and/or storage of the commercial products in the supply chain are called transportation units. Transportation units which can be created using parcels, cases, pallets, barrels, sacks, bags and etc. may contain any commercial product or more than one commercial product. Transportation units are numbered using the SSCC (Serial Shipping Container Code) number in the GS1 System. You may access detailed information related to the SSCC number used for the identification for transportation units from the TOBB GS1 web page.

SSCC (Serial Shipping Container Code)

SSCC is a coding system with specified regulations designed for transport packaging and is used for the unique identification of transportation units. The identification and numbering of transportation units greatly facilitates logistic operations (transportation, shipping, distribution and all stocking operations) and increases efficiency of automation applications in logistic operations by bringing speed and accuracy. Every transportation unit is given a serial number which provides its identification during its lifetime (starting with with the moment of its production until it is not usable). SSCC contains a different number for each transportation unit. Even if several transportation units contain the same product, every transportation unit is given a different SSCC number, thus a serial number. The SSCC number is used as an access key to reach the identification of the transportation unit in the computer environment and the information related to its features. You may access detailed information on the SSCC number used for the identification of the transportation units in the TOBB GS1 web page.

SSCC is used in the PTS system. In the product transfers using the PTS system, the product DataMatrix information is accessed within the transportation unit by the given SSCC number. Please visit the guidelines web page for detailed information of the PTS web services and its regulations.

RFID (Radio Frequency Identification)

The Radio Frequency Identification (RFID) technology, is an identification method to identify objects singularly and automatically by using radio frequency.  Along with barcodes RFID provides the data exchange with an electronic method and basically consists of a label and a reader.

The RFID label consists of a silicon splinter, an antenna and a coating which enables to receive queries made by radio frequency and answering them. The splinter preserves the information regarding the object that it is placed on. The antenna transfers the object’s information to the reader using radio frequency. The coating on the other hand encloses the splinter and the antenna to place the label onto the object.  

Studies are made to use the RFID technology in Turkey to trace the parcels and thermo-tracing.