Q337 · What is the purpose of a Mock Recall? How do…

Q337 · Category G: Quality management and compliance systems (Q301–Q350)

A mock recall is a “fire drill” to test how your recall procedure and traceability system perform under real-world pressure. The purpose is not to recall products, but to test in a controlled setting whether you can complete all the key steps required for a real recall quickly and accurately within the specified time. The effectiveness of a mock recall can be assessed using the following key indicators: 1. **Speed**: How long did it take from starting the exercise to producing a complete, accurate list of distribution customers? (The usual target is within a few hours); 2. **Accuracy**: Is the distribution list 100% accurate? Does it include every customer who bought the target batch? Are the quantities correct? 3. **Coverage**: Can you successfully “contact” every customer on the list? (In an exercise, this could involve sending a simulated notification email); 4. **Completeness**: Was the recall SOP followed throughout the exercise? Were all required records and forms completed correctly?

📘 Regulatory basis

GDP requires recall procedures to be capable of being initiated promptly and effectively. Although the regulations do not prescribe how often mock recalls must be conducted, regular exercises are the best way to demonstrate to regulators that your recall procedure is genuinely “effective”.

📗 Drew Tang's recommendations

We recommend that clients conduct a mock recall exercise at least once a year. After the exercise, hold a review meeting to assess performance honestly, identify bottlenecks and opportunities for improvement, and document the findings. For example, if retrieving distribution data took too long, this may indicate that your IT system or record-keeping process needs to be improved. Keep the exercise report as an important quality record.

📕 Risk notice

A recall procedure that has never been tested in a drill is likely to fail when a real crisis occurs. If you cannot demonstrate to the regulator that your traceability system and recall procedure are rapid and effective, it may reasonably conclude that you would be delayed in responding to a real recall, putting the public at risk. A failed drill is not the problem; never conducting a drill is.

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Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

What is the purpose of a Mock Recall? How do you assess its effectiveness?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang