Medicine Product Recall events while few and far between should be treated as serious events and actioned quickly in order to safeguard patient safety. Chapter 6 of Good Distribution Practice provides guidance on what measures a WDA holder should put in place to ensure recalls are handled appropriately. As it is a requirement for a WDA holder to have processes in place to handle recall events routine review is an effective way to ensure processes are appropriate and effective the below points identifies some interesting considerations when reviewing a recall procedure.
1. Communication, Surveillance and Escalation
Are there strong processes in place to ensure that notifications from the MHRA and suppliers are received by the organisation.
If shared mailboxes are in place ensure that all essential staff have access and have visibility.
Employee induction for senior staff including RPs should include checks to ensure work mailboxes are subscribed to relevant regulatory alert systems such MHRAs “Alerts, recalls and safety information: medicines and medical devices” and that contact details are added to relevant contact lists.
Does the Recall SOP have a clear process for escalation to the RP regardless of where the notification is received. If the RP is off-site or a contract RP is it clear to staff who the RP is and how best to contact them.
2. Traceability
Ensuring that your system is adequately set up to be able to accurately trace stock through your site is essential to handling a recall event satisfactorily. Systems should be qualified and validated for data accuracy this includes regular verification checks.
There should be adequate controls to ensure returned stock which is subject to a recall is not returned to saleable stock.
3. Adequate Testing
It is a GDP requirement that the recall process is tested annually. However, this does not mean it has to become a box ticking exercise real value can be attained from robustly testing the recall system. Below are some different criteria which can be used to identify any gaps.
Considering setting up mock recalls that only notify through certain specific channels such as via office phone outside of working hours or via a shared mailbox. In a real-world scenario third parties may not use the agreed proper channels i.e. the Out of Hours Contact list in the SOP appendix. Testing response times to specific channels will identify potential gaps in the system which can be addressed.
Ensure that any mock recall verifies physical space for recalled stock to be quarantined, if required.
Carry out tests on stock which has been returned, ensure processes are in place to prevent returned stock can be returned to saleable conditions if a recall has been initiated.
4. Training
With any system training is key to ensuring the process is followed and well embedded across the organisations operations. With regards to recall the annual mock recalls are a good way to test training, consider setting up mock recalls to target certain teams as a way to test their training.
Annual GDP refresher training should include elements regarding recall to ensure all staff are aware of their responsibilities.
Induction training should include dedicated training on recalls which should extend further than SOP read and understand training especially for staff who play vital roles. Verification of training should be implemented.
5. Customer Trust and Brand Reputation
Once trust is lost, brand reputation can be difficult to recover, not just with the end consumer but also with wholesalers, suppliers, and regulatory bodies. A poorly managed recall can raise concerns about an organisation’s reliability and regulatory compliance, leading to loss of business opportunities and damage to long-standing relationships.
Ensuring transparency in recall communication can help maintain confidence among stakeholders. Clearly outline the steps taken to manage the recall effectively, reassuring partners that the situation is under control.
Proactive engagement with wholesalers and healthcare providers can help mitigate reputational damage. Providing support during recall events, such as guidance on handling affected stock and offering replacement options, can reinforce trust and credibility.
To summarise, recalls are serious events which an organisation should be prepared to respond immediately too in a controlled manner. The above points should provide some interesting points of view to assess an organisations recall processes and identify any potential gaps which can be addressed.
