Traceability as a tool to ensure the quality of medicines

Traceability as a tool to ensure the quality of medicines

One of the main obligations of the health authorities, by the World Health Organization and its regional offices, It is to ensure that citizens have access to quality, safe and effective medicines. For this, first of all, necessary to ensure control, all drugs were legitimate, registered and issued by an authorized manufacturer. Secondly, to all products, produced in the country, shall apply the requirements of good manufacturing practices (GMP, Good Manufacturing Practices). finally, It needs to monitor the implementation of these conditions throughout the supply chain and their compliance with good practices in the implementation of (GDP, Good Distribution Practices) in the country. Besides, post-registration must be monitored, to monitor the application of the product and report the possible failure or adverse effects in clinical use.

Traceability drugs is unambiguous and definite identification of each pharmaceutical product, which will be released to the market, to track its movement throughout the supply chain from the manufacturer's laboratory / point of import to the patient receiving it.

medicines, covered by the traceability system, We shall be identified by a unique code in accordance with the recommendations of GS1 standards and contain the commercial product code, Global Trade Item Number (GTIN) and a unique serial number. This information can be integrated into any storage medium, provided it complies with the above standards, So, that each manufacturer can select the most appropriate storage medium for their products (whether it is a linear bar code, GS1 DataMatrix, an RF tag, or any other). Regardless of the information storage medium must always be represented in the form of visually perceivable, that it could read the patient.

Implementation of the National traceability system should achieve the following objectives:

  • Regulation of sales of medicines on the national level;
  • Prevent product from the standard deviation and distribution of counterfeit
  • drugs;
  • Detection of duplicate product codes;
  • Increase efficiency and reduce health system costs;
  • Providing patients with quality, reliable and effective drugs;
  • Minimizing errors in shipment;
  • Opposition to theft and falsification of goods;
  • Promote the effective withdrawal from the market of goods;
  • Evaluation of real-time consumption of each type of drug;
  • Promoting rational use of medicines.
*источник Healthcare Local Cases GS1 Argentina
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