Once a product recall has been initiated, the process must be monitored to ensure it is completed within the stipulated timeframe. A check must be performed to evaluate the recall's effectiveness. Following this, an investigation must be carried out to study the reason for the recall, and remedial action must be taken to ensure the defect does not recur.
When a stock of recalled drugs is received, it must be
placed under quarantine, in a segregated place, with no chance of being mixed
up with other products. Entry to this area must be restricted to authorized
personnel only. Samples must be drawn, and testing must be performed to identify the
root cause of the defects.
Once this has been established, corrective and preventive
actions (CAPA) must be drawn up and implemented.
Based on the investigation results, the defective product may be reprocessed or destroyed after due authorization. Generally, reprocessing is permitted only if it is sure to produce a product that will meet the same quality requirements after the reworking. Reprocessed batch details must be carefully monitored throughout their shelf life, and the records must indicate the identity as a reprocessed batch.