PHARMACEUTICAL INDUSTRY


Track and Trace is the operation in which the past and current status information of each product is recorded.

With the ITS Project every drug unit in Turkey is being tracked and recorded with the Track and Trace method. All the drugs in the market are tracked on the basis of packages using keys of GS1 standards. The serialization providing the uniqueness of the units is ensured by the Data Matrix code instead of formerly used barcode. The ability to track each drug unit is provided by gathering the information of each unit in every single step and action; and traceability is provided by its pedigree. Thus the products can be traced at every phase from its manufacturing until their consumption.

 


Data Matrix

To provide the traceability it is needed to assign a unique registration number to each drug unit.

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

Serial Number – SN: The unique registration number 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.

With the unique code that is acquired through these data the product becomes traceable. The conversion of these codes into DataMatrix and its usage on drug units, the tracking and tracing of the drugs has become obligatory since October 1, 2009.


Pharmaceutical Track and Trace System (ITS)

The Pharmaceutical Track and Trace System works through the notification of action types and Data Matrix information that is sent from the system stakeholders to the system center through web services. The Data Matrixes which are notified with production notifications by the manufacturer stakeholders are recorded to the system database as products able to move within the supply chain. After this registration, in other words the manufacturing notification, stakeholders like manufacturers, importers, exporters, warehouses, pharmacies, reimbursement companies, hospitals and other drug consuming centers which are part of the supply chain can move registered products according to certain rules. Transactions like buying, selling, reimbursement, recalls are notified to ITS in accordance with certain authorization and communication rules.

ITS communicates with its stakeholders through web services. All the notifications from the production of the drug until it reaches its last user are as follows; production, import, dispatch, exportation, dispatch cancellation, purchase, purchase return, consumption, deactivation and dispatch query. ITS where all this data is collected serves the collected and made meaningful information to the interrogators in terms of certain rules.  With ITS notifications are made for about 2 billion manufactured/imported drug units.