QMS SOP Template: Product Recall Management

Published: July 2025
Pages: 18

• Special Pricing for Emerging Economies

A pharmaceutical product recall Standard Operating Procedure (SOP) should align with several key regulatory requirements to not only ensure compliance but protect public health. While both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) share the goal of protecting public health through effective product recalls, their approaches differ in structure, scope, and regulatory expectations. The US FDA requirements are governed by 21 CFR Part 7, which outlines voluntary recall procedures, classification and public notification. EMA operates under a decentralized system. While the EMA coordinates recalls for centrally authorized products, national competent authorities handle recalls for nationally authorized medicines.

This SOP includes a template that helps the user to establish a clear and systematic process for the initiation, coordination, and execution of product recalls within the pharmaceutical organization. The purpose of this SOP is to ensure that any product deemed potentially harmful, defective, or noncompliant with regulatory requirements is promptly and effectively removed from the market.

When developing a global recall SOP, it is wise to build in flexibility to accommodate both centralized and decentralized regulatory models.