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