Standard Operating Procedure for Handling Customer Complaints

1) Purpose

The purpose of this SOP is to establish a procedure for the effective handling of customer complaints to ensure timely resolution and continuous improvement of product quality and customer satisfaction.

2) Scope

This SOP applies to all customer complaints related to pharmaceutical products manufactured by the facility.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Customer Service Personnel:

Responsible for receiving, documenting, and forwarding customer complaints to the QA department.

3.2 Quality Assurance (QA) Personnel:

Responsible for investigating complaints, determining root causes, and implementing corrective and preventive actions (CAPA).

3.3 Department Managers:

Responsible for ensuring that complaints are addressed in accordance with this SOP and for implementing necessary changes to prevent recurrence.

4) Procedure

4.1 Receipt and Documentation of Complaints:

4.1.1 Receive customer complaints via phone, email, or other communication channels.
4.1.2 Document the complaint details using the Customer Complaint Form.
4.1.3 Forward the documented complaint to the QA department for investigation.

4.2 Investigation of Complaints:

4.2.1 QA personnel must investigate the complaint to determine the root cause.
4.2.2 Review production records, testing data, and other relevant documentation.
4.2.3 Interview relevant personnel to gather additional information.
4.2.4 Document the findings of the investigation, including the identified root cause.

4.3 Implementation of Corrective and Preventive Actions (CAPA):

4.3.1 Develop CAPA plans to address the root causes of complaints.
4.3.2 Implement CAPA plans promptly to prevent recurrence of the issues.
4.3.3 Monitor the effectiveness of CAPA plans and make adjustments as necessary.

4.4 Communication with Customers:

4.4.1 Communicate investigation findings and resolution actions to the customer.
4.4.2 Provide customers with updates on the status of their complaints as needed.
4.4.3 Document all communications with the customer regarding the complaint.

4.5 Documentation and Review:

4.5.1 Document all steps of the complaint handling process, including receipt, investigation, CAPA implementation, and customer communication.
4.5.2 Review complaint records regularly to identify trends and areas for improvement.
4.5.3 Ensure all complaint records are complete, accurate, and stored securely.

5) Abbreviations, if any

QA – Quality Assurance
CAPA – Corrective and Preventive Actions

6) Documents, if any

1. Customer Complaint Forms
2. Investigation Records
3. CAPA Plans
4. Complaint Logs

7) Reference, if any

1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ICH Q10 Pharmaceutical Quality System

8) SOP Version

Version 1.0