Standard Operating Procedure for Handling of Returns and Rejected Goods

Purpose

The purpose of this SOP is to establish procedures for the systematic handling of product returns and rejected goods, ensuring proper documentation, evaluation, and disposition in compliance with Good Distribution Practice (GDP) guidelines.

Scope

This SOP applies to all personnel involved in the receipt, evaluation, and disposition of returned goods and rejected products within the pharmaceutical distribution facility.

Responsibilities

• The Returns Coordinator is responsible for overseeing the handling of product returns and coordinating return processes with customers and suppliers.
• The Quality Assurance (QA) Department is responsible for evaluating returned goods and rejected products to determine their disposition and compliance status.
• The Warehouse Management Team is responsible for managing returned goods and rejected products within the storage facility.

Procedure

1. Receipt of Returned Goods:
   • Receive returned goods in a designated returns area and document receipt details, including product information, quantity, and reason for return.
   • Inspect returned goods for damage, tampering, or expiration and segregate them from regular inventory.
2. Evaluation and Disposition:
   • Forward returned goods to the QA Department for evaluation and determination of disposition.
   • Conduct a thorough assessment of returned goods to determine compliance status, including visual inspection, testing, and documentation review.
   • Classify returned goods based on evaluation results as acceptable for resale, rework, destruction, or quarantine.
3. Documentation and Recordkeeping:
   • Maintain detailed records of returned goods, including receipt, evaluation, disposition, and final disposition outcomes.
   • Document any deviations or non-compliance issues identified during the evaluation process and the actions taken to address them.
4. Disposition Execution:
   • Implement appropriate disposition actions based on evaluation results, such as restocking, return to supplier, destruction, or rework.
   • Ensure proper labeling and segregation of goods based on their disposition status to prevent unintended use or distribution.
5. Customer Communication:
   • Communicate disposition decisions to customers or suppliers as applicable, including notification of product replacements, credits, or refunds.
   • Provide timely responses to customer inquiries or complaints regarding returned goods to maintain customer satisfaction.

Abbreviations

• QA – Quality Assurance
• GDP – Good Distribution Practice

Documents

Reference documents related to handling returns and rejected goods may include:

• Returns authorization forms
• Returned goods evaluation reports
• Disposition records
• Correspondence with customers or suppliers

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0