Standard Operating Procedure for Handling of Complaints

1) Purpose

The purpose of this SOP is to define the procedure for receiving, documenting, evaluating, and resolving complaints related to pharmaceutical products in order to ensure customer satisfaction and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in receiving and handling complaints within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Customer Service Representative
– Receive complaints from customers and document them accurately.
– Forward complaints to the appropriate department for investigation.
3.2 Quality Assurance (QA) Personnel
– Investigate complaints thoroughly and promptly.
– Determine root cause and assess product impact.
– Implement corrective and preventive actions (CAPA) as necessary.
3.3 Regulatory Affairs
– Ensure complaints are evaluated for regulatory reporting requirements.
– Submit necessary reports to regulatory authorities within specified timelines.

4) Procedure

4.1 Receipt of Complaints
4.1.1 Receive complaints through designated channels (e.g., phone, email, complaint form).
4.1.2 Document complaint details including product name, batch number, date of complaint, and nature of complaint.
4.2 Evaluation and Investigation
4.2.1 Assign an investigator to evaluate the complaint.
4.2.2 Gather relevant information and perform an investigation to determine root cause.
4.3 Corrective and Preventive Actions (CAPA)
4.3.1 Implement immediate corrective actions to address