Standard Operating Procedure for Handling of Product Recalls

Purpose

The purpose of this SOP is to establish procedures for the effective management and execution of product recall processes within the pharmaceutical distribution facility, ensuring timely and compliant recall activities to protect public health and safety.

Scope

This SOP applies to all personnel involved in the identification, initiation, coordination, and execution of product recall activities within the distribution facility, including quality assurance professionals, regulatory affairs personnel, and senior management.

Responsibilities

• The Quality Assurance Manager is responsible for overseeing product recall processes and ensuring compliance with regulatory requirements, company policies, and industry standards.
• The Regulatory Affairs Manager is responsible for liaising with regulatory authorities and coordinating communications related to product recalls, including submission of recall notifications and updates.
• All personnel involved in product recall activities are responsible for following procedures outlined in this SOP and actively participating in recall planning, execution, and follow-up activities as assigned.

Procedure

1. Recall Plan Development:
   • Develop a written recall plan outlining procedures, roles, and responsibilities for managing product recalls, including criteria for initiating recalls, communication strategies, and recall effectiveness checks.
   • Review and update the recall plan periodically to reflect changes in regulatory requirements, company operations, or product portfolios, ensuring that it remains current and effective.
2. Recall Initiation:
   • Initiate a product recall promptly upon identification of a potential safety or quality issue that poses a risk to public health or requires corrective action, following established criteria and decision-making processes.
   • Notify relevant internal stakeholders, including senior management, quality assurance, regulatory affairs, and production departments, of the recall initiation and provide instructions for immediate action.
3. Communication and Notification:
   • Prepare and disseminate recall notifications to affected customers, distributors, and regulatory authorities, providing clear and concise information on the reason for the recall, affected products, and recommended actions.
   • Coordinate with regulatory affairs personnel to ensure timely submission of recall notifications to regulatory authorities in accordance with regulatory requirements and reporting deadlines.
4. Recall Execution:
   • Execute recall activities according to the established recall plan, including retrieval of affected products from the market, segregation and quarantine of recalled products, and disposition or destruction of recalled inventory.
   • Monitor and track recall progress, including product recovery rates, customer responses, and completion of recall tasks, to ensure timely and effective execution of recall activities.
5. Recall Effectiveness Evaluation:
   • Conduct effectiveness checks following completion of recall activities to assess the success of the recall process in removing or correcting affected products from the market and mitigating associated risks.
   • Document and evaluate recall effectiveness data, including product recovery rates, customer responses, and any residual risks or issues identified during recall execution, and implement corrective actions as necessary.

Abbreviations

• SOP – Standard Operating Procedure

Documents

Reference documents related to handling of product recalls may include:

• Product recall plan
• Recall notification templates
• Regulatory guidelines on product recalls
• Recall effectiveness evaluation reports

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0