Harmonizing Global Efforts Against Counterfeits - Pharmaceutical Technology

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Harmonizing Global Efforts Against Counterfeits


Pharmaceutical Technology
Volume 36, Issue 12

The GS1 system (see Figure 1) includes standards for a number of factors.

  • Identification (i.e., the Global Trade Item Number (GTIN) and the Global Location Number (GLN), known as “keys”.
  • Capture—the “keys” can be captured in “carriers” (i.e., barcodes such as linear or 2-dimensional, or RFID).
  • Sharing of three types of data: Master Data (e.g., includes data elements for product item data: GTIN, description, unit of measure etc.), Transactional Data (e.g., business-to-business messages for purchase order, delivery note, invoice) and Event Data (e.g., Electronic Product Code Information System (EPCIS) to capture and share the “who,” “what,” “where,” and “when” of the products moving through the supply chain.

In terms of challenges, Kite says the biggest difficulty facing manufacturers is the number and variability of regulations that international pharmaceutical manufacturers are required to comply with. “This challenge could be overcome by harmonisation of all regulatory bodies to the GS1 system, for example, using the GTIN for identification, lot/batch number, expiry date and serial number application identifiers for data attributes and the GS1 datamatrix (a 2-dimensional barcode) for carrier type. A recent whitepaper by McKinsey and Co. advocates such an approach (1),” she says. “Another big challenge is the operational changes that manufacturers need to make to their product lines to comply with the variable regulations. In terms of coding, application of serialisation on the production line is a particular challenge; some manufacturers are opting to apply serial numbers at the end of the production line for now.”

With the pharmaceutical supply chain becoming increasingly global, the World Health Organization (WHO) has pointed out the importance of achieving traceability across borders. “We need to be able to trace products across the world to secure the supply chain and protect patients,” says Kite. In terms of the approach used by GS1, Kite explains that its Global Traceability Standard for Healthcare suggests the minimum model to be implemented is the “One-up, One-down” model, which can be achieved given the highly regulated nature of healthcare (2).

For example, one up would mean traceability from the manufacturer/distributor to the hospital and one down would mean traceability to the patient/enduser. This model involves point-to-point information sharing for day-to-day operations. “However, traceability is only as strong as its weakest link—if one link breaks, traceability across the supply chain ends at that point,” she says.

References

1. McKinsey and Co., “Strength in Unity: The Promise of Global Standards in Healthcare” (Whitepaper), http://www.mckinsey.com, accessed Nov. 9. 2012.

2. GS1 website, “Global Traceability Standard for Healthcare,” http://www.gs1.org/healthcare/, accessed Nov. 9, 2012.


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