Individual packs now need serialisation numbers, in much the same way a car has a registration plate. It ensures that pharmaceutical suppliers can track and trace every drug pack to its source of manufacture.
At Pharmapack 2014, Domino Printing Science’s EU Life Sciences sector manager Bart Vansteenkiste spelt out six reasons why drug companies should take action.
- Multiple physical formats and artwork formats combined with data requirements make codes technically challenging to print. A high number of rejects are likely at the pilot line stage.
- Creating a unique, non-predictive number is difficult. Who will issue the numbers - the government, the brand owner, GS1 or in some cases all three?
- Each country or region is different. For manufacturers supplying global markets, production lines and production reporting will have to be tailored to local legislative requirements.
- Successful solutions will include multiple suppliers. Demand for knowledgeable and established suppliers will be high and manufacturers should select their suppliers now before order books are full.
- The item and its data asset must stay connected – from the pallet through to the shipper case to the individual pack. This is not easy!
- Global Trade Item Number (GTIN) management can be poor. If there are multiple GTINs on a pack and one correctly identifies the medicine and the dosage and the other does not, how will pharmacists know which to scan? Is it safe to dispense?
Many countries have passed their own serialisation legislation: in the EU it is called the Falsified Medicines Directive (FMD); the Drug Quality and Security Act in the USA and governing bodies in Brazil (ANVISA); Argentina (ANMAT); South Korea (KNIH) and China (SFDA) are driving legislation.
Manufacturers subject to any of these schemes are now engaged in a race against time to implement serialisation ahead of deadline.
For further information on how to overcome the challenges of serialisation, please contact julia.felgate@domino-uk.com for Domino’s latest White Paper – The Hidden Challenges of Pharmaceutical Serialisation.
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