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 any immediate safety concerns.
4.3.2 Develop and implement CAPA to prevent recurrence of the issue.
4.4 Resolution and Communication
4.4.1 Communicate findings and resolutions to the customer in a timely manner.
4.4.2 Close the complaint file once resolution is confirmed and documented.
5) Abbreviations, if any
– CAPA: Corrective and Preventive Actions
– QA: Quality Assurance
6) Documents, if any
– Complaint Handling Log
– Investigation Reports
– CAPA Documentation
7) Reference, if any
– FDA Guidance for Industry: Handling and Reporting of Quality Issues
– ICH Q10 Pharmaceutical Quality System
8) SOP Version
Version 1.0