Serialized Barcode Printing Solution for Drug Traceability: An Architectural Design and Approach

Abstract

Medicine serialization seems to be a key to both counterfeiting and the complex supply chain of the pharmaceutical industry, including recalls and returns. Though there are countries that use serialization as a legal necessity, it is still a developing topic within the industry. Serialization is not just for anti-counterfeit technology but also to use supply chain and stock management more proficiently. The design of the Barcode is a fundamental requirement as per Healthcare Distribution Alliance (HDA) guidelines for serialized products. Encoding Barcodes on pharmaceutical drugs with critical product attributes is necessary for tracking and validating product sources. Since the serialization guidelines are regulated, small-scale pharmaceutical companies are struggling to comply with regulations due to heavy investments. Printing Serialized labels with barcodes required specialized third-party systems and software. The cost of third-party systems that integrate with ERP and Serialized systems for exchanging data is very expensive. On the other hand, the operational and sustainability costs of these systems will be an additional year-to-year cost for the company. Aim: This Study investigated the feasibility of designing a barcode printing solution for drug traceability. Material and Method: A case study has been carried out at a USA-based generic pharmaceutical company to print serialized labels using their enterprise Resource planning (ERP) integrated with the packaging line. Result: This dynamic solution for serialized label printing saves the company a significant number of resources and money, as they do not need to buy any specialized third-party system to print the label or send back the product to the packaging line. Conclusion: In this paper, we implement and validate a dynamic solution to print 2D data matrix and 1D Linear barcodes successfully within an ERP system by eliminating the need for a specialized third-party printing system.