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IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic March 2 – 4, ... - page 5 / 15

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Chapter 7: Products Recall

Objective

Verify that a system and procedures are established to recall from the market promptly and effectively, products known or suspected to be defective.

Main Aspects

SOP for Recall

Designated Responsible Recall Person

Distribution Records

Written progress report and reconciliation

Effectiveness of procedures checked

Secure segregated storage of all recalled products

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