Serialization may be defined as assigning a unique serial number for each of carton of the pharmaceutical products. This unique serial number is achieved by applying 1D/2D code on the cartons or marking the cartons through RFID technology. After applying a unique serial number on the carton, it should be checked whether this process is done right. The cartons whose unique serial number is not right must be rejected from the production line according to the pharmaceutical industry that implements the GMP rules firmly.
Assigning unique serial numbers on the pharmaceutical cartons is only a small part of the serialization process. Here, the greatest challenge is to manage the data correctly which is used during the process of assigning a unique serial number for cartons. During the process of creating, applying and reporting data, it is necessary to use software which is designed in compliance with the standards (GAMP 5, 21 CFR Part 11 etc.) used in the pharmaceutical industry for computerized systems. Apart from this, there is a track and trace infrastructure which consists of different layers, which is regarded by the pharmaceutical industry. The layers of this infrastructure guarantees that track and trace processes produce stable and accurate outcomes. The software which manages the data management of the serialization process is in the track and trace infrastructure in LEVEL 2. This software has to use EPCIS, CBV industry standards to communicate LEVEL 3.
In the following part of our essay, we will try to explain the process of serialization for pharmaceutical cartons in detail step by step.