The many faces of traceability
In common discussion on pharmaceutical serialization, track & trace means traceability of medicines from the manufacturer to the patient to ensure product authenticity.
On the other hand, the companies employ ERP systems for traceability of products and their components from sources through the logistics to gain supply chain visibility. This is very useful in case there is a defect in a sourced component: broken semiconductor components for electronics, spoiled food sources. Traceability makes product recalls easier and more precise.
This is also the case when products in the supply chain take a diversion. Let’s discuss the European pharmaceutical market under the Falsified Medicines Directive (FMD). This diversion could be an acceptable one, like a wholesaler selling a shipment of products to another wholesaler or a parallel importer (“grey imports”). In a the more complicated supply chain the purchaser of a shipment is required to verify the unique identifiers of the products. Repackaging products breaks the visibility, but the repackager is required both to decommission the unique identifiers of the original product and commission new unique identifiers to be tracked.
An unacceptable diversion would be when a product shipment, e.g. a delivery truck, is stolen. This breach must be detected and the unique identifiers reported to the EMVO as stolen ones to prevent re-entry of the unique identifiers to the supply chain. Why so? The contents of the stolen packages may have changed or new packages might have been produced with copied codes but unsafe contents – or the cold chain may have been broken.
Traceability is about protecting the consumer
For food products, traceability is also viewed the other way round: the consumer wants to know and be sure where the ingredients of his food product originate from. Thus, producer-identifying timestamps on eggs, names of farms in meat products. This process is for the end customer to identify the sources of food products, but not for authentication. The data can be easily copied or falsified.
Some pharmaceutical track & trace plans include a similar possibility for the patients: e.g. the Russian concept includes a phone app that the patient can use to trace back the logistics chain of the specific product to the manufacturer.
In comparison to the agricultural products, the pharma track & trace models do not include information before the manufacturer of the final product, or marketing authorization holder. There is some discussion about visibility to the APIs and excipients included in the medicines, though.
For the pharmaceutical industry, we offer services of an experienced full-service packaging, device assembly, and serialization and track & trace automation integration company. With experience from 30 years in the pharmaceutical industry, and of a thousand production & packaging line upgrades or new installations, Servicepoint can help you throughout the whole serialization projects. Call us for professional help!
Iiro Jantunen, D.Sc. (Tech.), CTO
Servicepoint Oy — the reliable partner for the manufacturing industry
CTO, Chief Technology Officer
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