Behind the three words of the title, there are many different meanings, and a lot of confusion, which this article will seek to clarify. This is one of the darkest areas in the industrial world, and especially the pharmaceutical industry. All project managers in this sector are currently focused on track and trace projects and ways of softly implementing new coding requirements on production lines with a minimum of immediate investment, but with enough attention to prepare the coming years and anticipated evolutions in regulation, such as aggregation.
So, identity, integrity, authenticity, track and trace, aggregation – it is worth taking some time to clarify these terms and what is it hidden behind them.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is pushing to put a unique code in place for secondary packaging, to bring an identity to each pack, even from the same batch number. By using this unique number, everybody will be able to identify one pack from another. Pack 1 and pack 2, from the same batch, produced the same day on the same production line and with the same expiry date, are different, because they have two different identities, two unique codes. This unique code defines the product itself, its production date, from which country, from which production line, its expiry date, at what point in the batch it was produced (beginning, middle or end) just as your passport defines who you are, where you are from, and so on. To conclude, a unique code defines the pack’s identity.
As a producer, you have to follow your production, not only on your production lines and plants, but also through the complete supply chain from distribution centres to retailers and to customers or patients. You have already traced your products by giving them an identity. If you’re able to check these identities along the supply chain, you’ll be able to track them. It is rather like several Customs controls at an airport. The different Customs officers will successively check your identity or passport, and are able to trace your complete trip from one country to another.
The EFPIA also recommends multiple controls to prevent counterfeiters or smugglers from introducing fake products on a legal product flow or to divert real products from their original destination to another one. To conclude this part, by defining the identity of your product and by checking it as much as possible from plant to customer, you track and trace your production.
