Supply chains, in general, are vulnerable to risks, especially regarding to traceability. In the pharmaceutical industry, it has generated facts all over the world that show the circulation of illicit medicines. Sub-Saharan Africa, India, Central, and South America, are the regions where a higher incidence is reported, with an annual increasing % of medicines being ilegal. The identification of producing economies and transit points in the Supply Chain is important for challenge the illicit market.
The traceability throughout the logistics system is a requirement in the drugs supply chains, then, it is necessary that products are correctly identified, which means that they can be identified in an unique way in each control point (ISO/IEC FDIS 15459-4:2014; ISO 22005:2007).
The unique identification is supported by the ISO/IEC FDIS 15459-4:2014 standard, which in section 4 standardizes the form of identification to all packaging levels and the relationship between the codes of each level. Its proposal focuses on all the actors in the chain using the standard to communicate and guarantee interoperability between information systems.
In the health field, Automatic Identification and Data Capture [AIDC] has been considered by the regulatory agencies as crucial in patient safety and in the accuracy and reliability of logistics. Since 80´s, the Healthcare Industry Bar Code [HIBC] has been used it as a way to capture data quickly and safely. Promoted by the International Medical Device Regulators Forum [IMDRF], with members such as the Food and Drug Administration [FDA] of the United States of America, the European Commission with 4 issuing entities as GS1, ICCBBA - International Council for Commonality in Blood Banking Automation, IFA GmbH and Health Industry Business Communications Council (HIBBC), an international project called Unique Device Identification [UDI] started, which includes the AIDC as a center in the marking of the loads and as a data standard in the interoperable databases.
The UDI was imposed as Federal Law in the United States in 2013, as the basis for its generalization from that year.
The fact is that Information and communication technologies have revolutionized the supply chains, have made them safer and more efficient, the use of Auto-ID [Automatic Identification] and EDI [Electronic Data Interchange] technologies are supporting the advent of enabling technologies for logistics 4.0, now we have to use it correctly.
Prof. Dr. C. Igor Lopes Martínez
Head of the Department of Industrial Engineering / Faculty of Industrial Engineering
Head of the Discipline of Process Management and Supply Chains
Technological University of Havana José Antonio Echeverría - CUJAE
Inchainge Education Associate / Certified Trainer
VCARE Academy Regional Representative / CSSC Certified Instructor
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