Product that has had a deviation, been returned or is awaiting a decision comes out of the picking flow. A block in the system is necessary, but while the product stays reachable on the shelf it can still be picked on a busy day, so the system block and a separate area on the floor work together.
The EU Good Distribution Practice guidelines (2013/C 343/01, section 3.2) ask for product awaiting a decision to be segregated physically or by a validated equivalent electronic system, and for falsified, expired, recalled and rejected product to be segregated physically at once in a dedicated area. The 2022 GDP inspection guideline of the Turkish Medicines Inspection Department looks for a quarantine and a rejected-goods section and asks whether these areas are locked with walls running up to the ceiling.
| Feature of the area | Reason |
|---|---|
| Marked and separate | Removes the risk of mixing |
| Restricted access | Stops unauthorised movement |
| Matched to records | Product, batch, reason and date are known |
Quarantine for a 2-8 °C product also takes place at 2-8 °C. The guidelines allow a returned cold-storage product back into saleable stock only if it is documented that it was kept in the authorised conditions throughout (section 6.3); a quarantine outside the cold room breaks that evidence. A marked, separated shelf inside the cold room solves it.
- The decision arrives in writing.
- The product is released or set aside for destruction.
- The physical move and the system transaction happen at the same time.
- The decision goes into the file.
Product that waits long takes space and gets forgotten; the decision time is set by product and quality system, and a reminder is generated when it passes.