Important to have a robust procedure for handling recalls. Have you tested your “recall” system? What will you do with the recalled product? Here are a few points to consider about your process:
- Set out responsibilities: recall, traceability and approval duties.
- Classes of recalls and what is the timeline on them.
- Staff training.
- Mock recall should be made if no recall in 12 months.
- What action has to be made when recalled products are in transit or your customer returning them back to you.
- How do you destroy them?
- Make sure you have accessible (MHRA, RP, out of hours, etc.) contact details
- Retain all your records for 5 years.
According to EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01) 6.5 Medicinal product recall:
- Recall operations should be initiated promptly and at any time.
- Recall should be recorded at the time it is carried out and records must be available
- Distribution records should be readily accessible to the person responsible for recall.
- Distributor must follow the instructions of recall message, which should be approved.
- The effectiveness of product recall should be evaluated regularly (at least annually).
- Progress of the recall process should be recorded for final report.
Subscribing to MHRA email alert is part of your recall procedure. This is an automatically generated alerts and recalls for drugs and medical devices via email. MHRA also sends `Weekly Field Safety Notices` emails to subscribers. This is a great way to track alerts. Tip: Every 12 months should you re-subscribe to keep your details up-to-date in MHRA data system to be able to receive all alerts.