Standard Operating Procedure for Product Recall and Market Withdrawal

Purpose

The purpose of this SOP is to establish procedures for the prompt and effective recall or market withdrawal of pharmaceutical products in the event of quality issues or safety concerns, in compliance with Good Distribution Practice (GDP) guidelines.

Scope

This SOP applies to all personnel involved in the distribution, quality control, and regulatory affairs departments responsible for managing product recalls or market withdrawals.

Responsibilities

• The Quality Assurance (QA) Department is responsible for initiating and coordinating product recalls or market withdrawals.
• The Regulatory Affairs Department is responsible for communicating with regulatory authorities and stakeholders regarding recall or withdrawal actions.
• The Distribution Department is responsible for executing recall or withdrawal activities and maintaining records.

Procedure

1. Identification of Recall or Withdrawal Trigger:
   • Any employee who becomes aware of a potential quality issue or safety concern with a product must immediately report it to the QA Department.
2. Evaluation and Classification:
   • The QA Department assesses the severity of the issue and determines whether a recall or market withdrawal is necessary.
   • Recalls are classified based on the level of risk to public health (e.g., Class I for serious risk, Class II for temporary or reversible effects, Class III for minor issues).
3. Recall Strategy Development:
   • Develop a recall strategy, including communication plans, recall scope, and target markets.
   • Assign responsibilities and establish a recall team to manage the process.
4. Notification to Regulatory Authorities:
   • Notify relevant regulatory authorities promptly according to regulatory requirements.
   • Provide detailed information about the product, reason for recall, and proposed actions.
5. Communication with Stakeholders:
   • Inform customers, distributors, and other stakeholders affected by the recall or withdrawal.
   • Provide clear instructions on how to return or dispose of the affected products.
6. Execution of Recall or Withdrawal:
   • Coordinate the retrieval, quarantine, and disposal of affected products in collaboration with the Distribution Department.
   • Monitor the progress of the recall and ensure timely completion.
7. Documentation and Reporting:
   • Maintain detailed records of all recall activities, including communication logs, product disposition, and regulatory correspondence.
   • Prepare and submit final recall reports to regulatory authorities as required.

Abbreviations

• QA – Quality Assurance
• GDP – Good Distribution Practice

Documents

Reference documents related to product recall and market withdrawal may include:

• Regulatory requirements for recall management
• Internal procedures for recall execution
• Communication templates
• Recall notification logs
• Product disposition records
• Final recall reports

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0