A medicine supply chain connects manufacturing, quality release, storage, distribution and dispensing. Each handoff transfers both a physical product and the information needed to identify it, handle it correctly and trace its movement.
Map the handoffs and their records
| Stage | Main operational question | Information passed onward |
|---|---|---|
| Manufacture and packaging | Does the batch match its approved specification? | Product, strength, quantity and batch identity |
| Quality release | Is the stock authorised for distribution? | Release status and associated records |
| Storage | Are the specified storage conditions maintained? | Location, lot, status and condition records |
| Distribution | Where did each lot go? | Dispatch and recipient details |
| Receipt and dispensing | Does the delivered product match the order and remain usable? | Receipt findings and any discrepancy |
In the United States, 21 CFR 211.142 addresses quarantine before quality-control release and appropriate storage conditions. Section 211.150 requires distribution procedures and records that allow the destination of a lot to be determined for recall. These provisions connect stock status with traceability.
Diagnose a delay at the correct stage
A late delivery can arise from different events: the product may be awaiting release, an order may be incomplete, or a shipment may be held because a storage condition needs investigation. Begin with dates and status changes rather than treating every delay as a transport problem.
WHO’s medicines work emphasises access to quality-assured products. Faster movement does not resolve a quality hold. The useful question is what evidence the responsible team needs to release the hold, correct the order or arrange replacement stock.
Keep packaging identity connected to the lot
Product identity, strength and lot information must stay connected through packaging and dispatch. For US drug manufacture, 21 CFR 211.130 includes controls for correct packaging and labeling and lot identification. A delivery record cannot reliably resolve a discrepancy if the physical pack cannot be matched to it.
At a handoff, record the quantity received, the product and lot identifiers, the condition of the shipment and the action taken on a discrepancy. This makes the next investigation specific: which units were affected, where they were held and who made the disposition decision.
Continue with Packaging and medicine availability for pack defects, Pharmaceutical serialization and aggregation levels for unit GS1 DataMatrix and SSCC parent-child tracking, and the packaging-layer guide for component terminology.
