First: quarantine, then investigate
Stock that has experienced an excursion should be segregated and placed in quarantine before assessment begins, not after. GDP treats product of uncertain status as unsuitable for supply until it has been assessed, and releasing stock while the investigation is still open is difficult to defend.
Quarantine here means a controlled status that prevents picking and supply. Physical segregation is preferable; a system status that reliably blocks allocation can be acceptable if it is validated and cannot be overridden without authorisation.
The evidence needed before a decision is possible
An excursion assessment is a comparison between what the product actually experienced and what the product is known to tolerate. Both halves are required, and the second half comes from the manufacturer or marketing authorisation holder, not from the wholesaler.
What to assemble
- The full temperature profile: duration, peak and minimum, not just the fact of a breach.
- Calibration status of the monitoring device covering the period concerned.
- Whether the device was measuring product temperature or ambient air temperature.
- Cumulative prior exposure for the same stock, where known.
- The manufacturer’s or MAH’s stated permitted excursion data for the specific product.
- The batch, quantity and location of all affected stock.
Why cumulative exposure matters
Permitted excursion data is normally expressed as a total allowance rather than a per-event allowance. A product that tolerates a defined period outside its labelled range has that budget consumed across its whole distribution history, not reset on each leg.
This is why an excursion that looks trivial in isolation can still require the manufacturer’s input: the wholesaler frequently cannot see what happened upstream. Where prior exposure is unknown, that uncertainty should be recorded as part of the assessment rather than assumed away.
The RP decision, and what it is not
The disposition decision belongs to the Responsible Person. The RP may conclude that stock can be returned to saleable status, that it should be destroyed, or that further information is needed from the manufacturer before a conclusion can be reached.
What the decision is not is an inference from the absence of harm. “The product looks fine” and “we have done this before” are not evidence. Where the manufacturer cannot or will not provide stability data for the specific excursion, the defensible position is normally that the stock cannot be returned to saleable stock.
Records that need to exist afterwards
The record should let a reader who was not present reconstruct the decision: what happened, what evidence was considered, what the manufacturer said, who decided, on what date, and what the disposition was. A one-line log entry stating the outcome does not meet that test.
Recurring excursions from the same route, vehicle, store or piece of equipment should feed the deviation and CAPA process rather than being closed individually. A pattern of individually-justified excursions is itself a finding.
Common questions
- Can we release stock if the excursion was brief?
- Only if the manufacturer’s permitted excursion data for that product supports it and the cumulative exposure remains within the allowance. Duration alone does not answer the question.
- The logger was out of calibration. Does that change anything?
- Yes. Data from an uncalibrated device cannot be relied on to demonstrate the product stayed within range, which usually makes the exposure unquantified rather than acceptable.
- Do we need to tell the manufacturer about every excursion?
- Not necessarily every one, but you need their stability position for any excursion you intend to justify a return to saleable stock on. Where your own procedure already carries their documented allowance, that can be sufficient.
- Who can make the final disposition decision?
- GDP Chapter 2 places decisions on final disposition of returned, rejected, recalled or falsified product, and approval of returns to saleable stock, with the Responsible Person.
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
- MHRA — Medicines: good manufacturing practice and good distribution practice