Standard Operating Procedure for Product Traceability and Recall Procedures

Purpose

The purpose of this SOP is to establish procedures for ensuring product traceability and implementing effective recall procedures in the event of product quality issues or safety concerns, in compliance with regulatory requirements and Good Distribution Practice (GDP) guidelines.

Scope

This SOP applies to all personnel involved in the distribution, storage, and handling of pharmaceutical products within the distribution facility, as well as external stakeholders, including suppliers, customers, and regulatory authorities.

Responsibilities

• The Quality Assurance (QA) Department is responsible for establishing and maintaining product traceability systems and coordinating recall activities.
• The Warehouse Management Team is responsible for maintaining accurate inventory records and facilitating traceability of products within the distribution facility.
• The Regulatory Affairs Department is responsible for liaising with regulatory authorities and managing communication during recall events.

Procedure

1. Product Identification and Coding:
   • Assign unique identifiers, such as batch numbers, lot numbers, or serial numbers, to each product batch during manufacturing.
   • Label products with clear and legible identification codes that facilitate traceability throughout the distribution chain.
2. Inventory Management and Tracking:
   • Maintain accurate records of product inventory, including receipt, storage, and distribution activities, in a centralized database or inventory management system.
   • Implement inventory tracking mechanisms to trace the movement of products from receipt to dispatch, including location history and handling details.
3. Traceability Systems:
   • Establish traceability systems that enable rapid identification and retrieval of affected products in the event of a recall or quality issue.
   • Link product identification codes to relevant documentation, such as manufacturing records, certificates of analysis, and distribution records.
4. Recall Procedures:
   • Develop a recall plan outlining roles, responsibilities, and procedures to be followed in the event of a product recall.
   • Activate the recall plan promptly upon identification of a product quality issue or safety concern, involving key personnel and stakeholders.
5. Communication and Notification:
   • Notify regulatory authorities and customers of the recall event in accordance with regulatory requirements and established communication channels.
   • Provide clear and concise instructions to customers regarding the return, replacement, or disposal of recalled products.
6. Recall Effectiveness Evaluation:
   • Conduct a post-recall evaluation to assess the effectiveness of recall procedures and identify areas for improvement.
   • Review the root causes of the recall event and implement corrective actions to prevent recurrence.

Abbreviations

• QA – Quality Assurance
• GDP – Good Distribution Practice

Documents

Reference documents related to product traceability and recall procedures may include:

• Product coding and labeling standards
• Inventory management procedures
• Recall plan and protocols
• Communication templates
• Post-recall evaluation reports

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0