The default position
Returned product leaves your control and re-enters it with an unknown history. GDP’s starting position is therefore that returned stock is not saleable until an assessment establishes that it can be. The burden sits with justifying the return to stock, not with justifying rejection.
Returned goods should be handled and stored separately from saleable stock until that assessment is complete.
What the assessment has to establish
- That the product was supplied by you and can be matched to the original despatch record.
- That it remained within its required storage conditions for the whole period it was out of your control.
- That it is within its expiry date and shows no evidence of tampering or damage.
- That the original packaging is intact and the product has not been repackaged or relabelled.
- That the customer holds it under conditions and for a period consistent with their own records.
- That the return is not connected to a complaint, recall or suspected falsification.
The transport conditions problem
The condition most often unevidenced is the temperature history while the product was with the customer and during its return. Without that evidence, a temperature-sensitive product generally cannot be returned to saleable stock, however short the absence.
Some operators address this with sealed, monitored return packaging or by restricting returns of cold-chain product entirely. Both are defensible; what is not defensible is an assumption that the customer stored it correctly.
The RP decision
Chapter 2 makes approval of any returns to saleable stock an RP responsibility, alongside deciding the final disposition of returned, rejected, recalled or falsified product. This is one of the duties inspectors most often expect the RP to exercise personally rather than through a delegate.
The record should show the criteria applied, the evidence considered, the decision and who made it. Where a delegate applies pre-defined criteria for routine low-risk returns, the delegation and the criteria both need to be documented and the exceptions must escalate.
Stock that cannot be returned to sale
Product that fails assessment should be quarantined and destroyed through a documented route, with records of quantity, batch and method. Destruction records are frequently reviewed at inspection because they are the endpoint of several other processes.
Common questions
- Can we return cold-chain product to saleable stock?
- Only where you can evidence the temperature was maintained throughout the period the product was out of your control. Without that evidence, the usual outcome is that the stock cannot be returned to sale.
- How quickly does a return need to come back to be acceptable?
- GDP does not set a period. Many operators define one in procedure as a risk control, but the substantive question is evidence of storage conditions rather than elapsed time alone.
- Does the RP have to approve every single return?
- The RP is responsible for approving returns to saleable stock. Routine low-risk returns can operate against documented criteria with delegated application, provided the delegation is recorded and exceptions escalate to the RP.
Sources
- Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use 2013/C 343/01
- MHRA Guidance Note 6 — applicants and holders of a Wholesale Dealer’s Licence or Broker Registration Fifth edition 2022, section 9 amended 2023