Returned products are separated from stock available for sale, physically and in the electronic system (Guide 4.2), and handled under a written, risk-based process that takes into account the special storage requirements and the time since first dispatch (7.3).
For acceptance into saleable stock, Guide 7.3 requires all of the following:
- The secondary packaging is unopened and undamaged, the product has not been recalled and was not returned for a quality defect.
- A product coming back from a pharmacy or hospital was returned within an acceptable period.
- The customer has shown that the product was transported and stored in line with its storage requirements.
- A trained and competent person has examined it.
- There is evidence that the product was supplied to that customer (delivery note or invoice number) and its batch number is known.
A product that needs low-temperature storage also needs a documented declaration that it was kept in the right conditions throughout: the delivery record, a visual check, whether the shipping pack was opened, how the product came back to the warehouse and whether it went into cold storage. If there was a deviation, a risk assessment must show the product's integrity. Giving a customer who returns often a container with a logger puts the evidence for this declaration in hand at the moment of return.