Serialisation and track-and-trace is software that gives every pack of a medicine its own unique number, and records each pack's journey from the plant to the pharmacy. Serialisation means giving each pack its own serial number. Track-and-trace means following the pack, using that number, through every company that handles it. Together, they make it possible to catch fake medicines, which are called counterfeits.
The number is printed on the pack in a small square barcode, called a 2D DataMatrix code, or sometimes in a QR code. The code holds four things: a code for the product, the pack's own serial number, the batch number and the expiry date. On the packing line, a printer prints the code, and a camera reads it back at once to check that it can be scanned. Packs are then put into cases, and cases are stacked on pallets. Each case and each pallet gets a number of its own, linked to the packs inside it. This link is called aggregation. Because of it, a distributor can scan one pallet and know every pack on it.
Regulators decide what must be recorded. America's law requires every prescription medicine pack to carry a serial number, and every company in the supply chain to exchange the pack records electronically. Europe requires a check of each pack at the pharmacy before it is sold. India requires barcodes on medicines for export. Inside India, the top 300 medicine brands must carry a QR code that buyers can scan.
Take, for example, a plant at Pithampur, near Indore, that exports a blood pressure tablet to America. It packs 1 lakh boxes in one batch. Each box gets its own number. The packing line puts 50 boxes into each case, and 40 cases on each pallet. The serialisation software sends the records to the American wholesaler through a shared network that drug makers and distributors use. When the wholesaler receives the pallet, it scans the pallet's code. It then knows exactly which 2,000 boxes arrived. Later, an American pharmacy scans a box with its pharmacy management software. The number is checked against the maker's records. If someone has copied the number on to a fake box, the check shows a box that was already sold, or a number that was never made.
The batch number and quantities come from the manufacturing execution system (MES). A pack with a complaint can be traced back to its batch, and from there into the quality management system (QMS). For medicines kept cold, such as vaccines, the pack records are often combined with temperature records from cold-chain logistics. Other ways to prove a product is genuine, such as marks that cannot be copied, are described in product authentication. The general idea is explained in track and trace.
How is this different from supply chain visibility? Visibility software shows where a shipment is right now. Serialisation records exactly which packs exist, and every hand each pack has passed through.