**Standard Operating Procedure for Handling of Complaints**

**Objective:**
To establish a standardized procedure for the prompt and effective handling of complaints received by
[Drug Distributor Name], in accordance with the guidelines outlined in WHO Technical Report Series
(TRS) 1025 Annex 7, section 8.1.

**Scope:**
This procedure applies to all employees responsible for receiving, documenting, investigating, and
resolving complaints at [Drug Distributor Name].

**Responsibilities:**
1. **Quality Assurance Manager:**
- Oversees the implementation of the complaint handling procedure.
- Ensures compliance with regulatory requirements and internal policies.
- Reviews and approves the resolution of complaints.

2. **Customer Service Representative:**

- Receives and documents complaints from customers or other stakeholders.
- Initiates the investigation process by gathering relevant information.
- Communicates with customers regarding the status and resolution of complaints.

3. **Quality Control Officer:**

- Conducts investigations into the root cause of complaints.
- Collaborates with relevant departments to implement corrective and preventive actions.
- Provides input to the Quality Assurance Manager for complaint resolution.

**Procedure:**

1. **Receipt of Complaint:**
- Customers or stakeholders can submit complaints through various channels, including phone, email,
or in person.
- Customer Service Representatives are responsible for promptly recording all complaints in the
Complaint Log.

2. **Initial Assessment:**
- Customer Service Representatives conduct an initial assessment of the complaint to determine its
severity and urgency.
- Classify complaints based on their impact on product quality, safety, or regulatory compliance.

3. **Investigation:**
- Assign a Quality Control Officer to lead the investigation into the complaint.
- Gather relevant information, including product details, batch numbers, and customer feedback.
- Conduct a thorough root cause analysis to identify the underlying issues contributing to the
complaint.

4. **Resolution:**
- Develop an action plan to address the root cause of the complaint.
 - Implement corrective and preventive actions to prevent similar issues from recurring in the future.
- Communicate the resolution plan and timeline to the customer, providing regular updates as
necessary.

5. **Follow-up and Closure:**

- Follow up with the customer to ensure satisfaction with the resolution of the complaint.
- Document the outcome of the investigation and any actions taken in the Complaint Log.
- Obtain final approval from the Quality Assurance Manager before closing the complaint.

6. **Documentation and Reporting:**

- Maintain accurate records of all complaints received and actions taken in a designated Complaint
Log.
- Generate periodic reports summarizing complaint trends, analysis, and resolution status.
- Share relevant information with management and other stakeholders for continuous improvement
purposes.

**Training:**
- Provide training to all employees involved in the complaint handling process to ensure familiarity with
this SOP and relevant regulatory requirements.

**Revision History:**
- Any updates or revisions to this SOP must be documented, including the date of revision and the
nature of the change.

**References:**
- WHO Technical Report Series (TRS) 1025 Annex 7: Good Storage and Distribution Practices for
Pharmaceutical Products

**Approval:**
This SOP has been reviewed and approved by [Authorized Personnel] on [Date]. Any questions or
concerns regarding this SOP should be directed to [Quality Assurance Manager].

Prepared by: Approved by: Date:

Mark Wendell L. De Castro George A. Go April 11, 2024

Pharmacist CEO