What the procedure needs to cover
A recall procedure should be capable of being executed at any time, including outside working hours, by people who may not have run one before. That places specific demands on the document.
- How a recall notification is received and who is authorised to initiate action.
- Out-of-hours contact arrangements for the RP and key personnel.
- How affected stock is identified from records, including partial batches.
- How stock on hand is immediately blocked from picking and despatch.
- How customers who received affected stock are identified and contacted.
- How returned recalled stock is segregated and controlled.
- Reconciliation of quantities supplied, returned and unaccounted for.
- Reporting to MHRA and the MAH, and closure of the recall.
Recall classification and urgency
MHRA classifies recalls by risk, and the classification drives the required speed and reach — including whether action is needed within hours and whether it extends to patient level. Your procedure should be able to operate at the fastest classification, because the timescale is not within your control.
Recall notifications may arrive at any point in the chain, including directly from a manufacturer, from MHRA, or via a customer. The procedure should not assume a single entry point.
Recall testing
A recall test — sometimes called a mock recall — exercises the procedure on a selected batch without an actual defect. It should measure the things that matter under real conditions: how long identification of affected stock took, whether customer contact details were current, how complete the reconciliation was, and where the process stalled.
A test that reports only “completed successfully” has not measured anything. The useful output is the timings and the gaps, followed by corrective action where the gaps were material.
Tests should be run at a defined frequency, and at least one should exercise the out-of-hours route, because that is where contact arrangements usually fail.
Reconciliation
Reconciliation compares what was supplied against what was recovered and accounts for the difference. Product already dispensed or administered is a legitimate part of that difference; product that simply cannot be traced is not, and points to a records problem worth investigating separately.
Unreconciled quantities should be quantified and explained rather than left as a residual.
The RP’s role
Coordination of recall operations sits with the RP under Chapter 2. In practice this means the RP should be reachable, should have the authority to stop supply immediately, and should sign off the reconciliation and closure. Recall procedures that route decisions through a commercial approval step tend to fail on timing.
Common questions
- How often should we run a recall test?
- GDP does not specify a frequency. Annual is common, and the justification should reflect your risk and the stability of your customer base. At least one test should cover the out-of-hours scenario.
- Do we need to contact every customer who received the batch?
- The reach depends on the recall classification. Your procedure needs to be able to identify and contact all recipients, with the extent of contact then determined by the classification and any MHRA instruction.
- Who can authorise stopping supply?
- The RP should be able to block supply immediately. If your process requires another approval first, that is a weakness worth removing before it is tested in a real recall.