A medicine can be physically present and still be held from distribution or dispensing. Unreadable product identity, a damaged closure or a mismatch with the order can require an investigation before the unit can be used.
Check the defect at the affected packaging layer
| Observation | First check | Follow-up record |
|---|---|---|
| Unreadable or incorrect identification | Product, strength, lot and approved artwork | Affected packs and labeling discrepancy |
| Damaged closure or seal | Integrity of the product-contact package | Condition, extent and quality assessment |
| Missing required leaflet | Approved pack configuration and component controls | Lot, component and disposition |
| Wrong presentation received | Order and dispatch details | Quantity, recipient and replacement action |
US requirements in 21 CFR 211.94 address protection and suitability of drug containers and closures. Section 211.130 addresses correct packaging and labeling, including checks before an operation starts. A receipt inspection should therefore distinguish a damaged shipping case from damage to the package protecting the medicine.
Determine how much stock is affected
Record the product, lot, location and quantity involved. Identify whether the observation concerns one unit, one case or a wider lot. Keep the affected stock under the applicable quality procedure while its disposition is decided.
A practical investigation asks when the defect was first visible, whether the same component appears in other packs and whether handling or packaging records explain the pattern. Photographs can help document the condition, while the batch and distribution records establish which units require attention.
Connect the finding with the supply decision
The immediate decision may involve reinspection, replacement, relabeling under an approved procedure, or a quality hold. Record the responsible decision-maker and the basis for releasing or rejecting stock so that the supply team can plan against a known status.
WHO also identifies price, shortages and falsified products as access barriers. A packaging investigation should retain its own unit of analysis: affected packs and lots, the defect found and the time needed to resolve it. Broader supply reviews can then combine that evidence with procurement and distribution records.
Use the medicine supply-chain guide to trace handoffs and Access to medicines for population-level coverage measures.
