Follow
1 Principle. Measures should be in place to promptly and effectively recall products known or suspected to be defective from the market.
2 The authorized person should be responsible for the execution and coordination of withdrawals. He/she must have sufficient staff to handle all aspects of the recall with the appropriate degree of urgency.
3 Written procedures should be established for the organization of any withdrawal activity, which are regularly reviewed and updated. Recall operations should be able to begin immediately at the required level in the distribution chain.
4 An instruction to store in a secure segregated area should be included in the written procedure when determining the fate of recalled products.
5 All competent authorities in countries to which a given product is distributed should be notified immediately of any intention to recall the product because it is defective or suspect.
6 Distribution records should be readily available to the authorized person, and should contain sufficient information to provide an effective authorization for wholesalers and direct supplies to customers (for exported products, including those who have received samples for clinical testing and medical samples). withdrawal
7 The progress of the withdrawal process should be monitored and recorded. The record should include the disposition of the product. A final report should be issued, including a reconciliation of the amount of product dispensed and recovered.
8 The effectiveness of withdrawal arrangements should be tested and evaluated from time to time.
