Standard Operating Procedure for Complaint Handling

Purpose

The purpose of this SOP is to establish procedures for the systematic and effective handling of complaints related to pharmaceutical products, ensuring timely investigation, resolution, and appropriate corrective actions, in compliance with Good Distribution Practice (GDP) guidelines.

Scope

This SOP applies to all personnel involved in the receipt, assessment, investigation, and resolution of complaints received from customers, distributors, or other stakeholders.

Responsibilities

• The Quality Assurance (QA) Department is responsible for overseeing the complaint handling process and ensuring compliance with SOPs.
• The Customer Service Department is responsible for receiving and documenting complaints from customers.
• The Quality Control (QC) Department is responsible for investigating complaints related to product quality.
• The Regulatory Affairs Department is responsible for reporting serious complaints to regulatory authorities as required.

Procedure

1. Receipt of Complaint:
   • Receive complaints through designated channels, such as customer service hotlines, email, or complaint forms.
   • Document all relevant details of the complaint, including product details, nature of the complaint, and contact information of the complainant.
2. Assessment and Categorization:
   • Assess the severity and validity of the complaint to determine the appropriate level of investigation.
   • Categorize complaints based on their nature (e.g., product quality, packaging issues, labeling discrepancies).
3. Investigation:
   • Assign investigation responsibilities to relevant departments based on the nature of the complaint.
   • Conduct a thorough investigation, including gathering relevant data, conducting laboratory tests, and reviewing production records.
4. Resolution and Corrective Actions:
   • Take appropriate actions to resolve the complaint, such as replacement, refund, or corrective actions to prevent recurrence.
   • Document all actions taken and ensure they are implemented within the specified timeframe.
5. Communication:
   • Keep the complainant informed of the progress and resolution of their complaint.
   • Provide feedback to customers on the outcome of the investigation and any corrective actions taken.
6. Documentation and Reporting:
   • Maintain detailed records of all complaints, investigations, and resolutions.
   • Prepare periodic reports on complaint trends, including analysis and recommendations for improvement.

Abbreviations

• QA – Quality Assurance
• QC – Quality Control
• GDP – Good Distribution Practice

Documents

Reference documents related to complaint handling may include:

• Standard operating procedures (SOPs)
• Complaint handling forms
• Investigation reports
• Corrective action plans
• Customer communication templates
• Complaint trend analysis reports

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0