Product recalls

6.1 Principle. There should be a system to recall from the market, promptly and effectively, products known or suspected to be defective.

6.2 The authorized person should be responsible for the execution and coordination of recalls. He or she should have sufficient staff to handle all aspects of the recalls with the appropriate degree of urgency.

6.3 There should be established written procedures, which are regularly reviewed and updated, for the organization of any recall activity. Recall operations should be capable of being initiated promptly down to the required level in the distribution chain.

6.4 An instruction should be included in the written procedures to store recalled products in a secure segregated area while their fate is decided. All competent authorities of all countries to which a given product has been distributed should be promptly informed of any intention to recall the product because it is, or is suspected of being, defective.

6.5 The distribution records should be readily available to the authorized person, and they should contain sufficient information on wholesalers and directly supplied customers (including, for exported products, those who have received samples for clinical tests and medical samples) to permit an effective recall.

6.6 The progress of the recall process should be monitored and recorded. Records should include the disposition of the product. A final report should be issued, including a reconciliation between the delivered and recovered quantities of the products.

6.7 The effectiveness of the arrangements for recalls should be tested and evaluated from time to time.