Standard Operating Procedure for Handling Customer Complaints and Product Recalls
1) Purpose
The purpose of this SOP is to establish procedures for receiving, documenting, investigating, and resolving customer complaints, as well as initiating and managing product recalls effectively within the pharmaceutical manufacturing facility.
2) Scope
This SOP applies to all personnel involved in handling customer complaints and initiating/recalling products within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Quality Assurance (QA) Team
- Receive and document customer complaints.
- Initiate investigations and coordinate with other departments.
- Coordinate product recall activities.
3.2 Manufacturing and Regulatory Affairs (RA) Teams
- Investigate root causes of complaints and non-conformances.
- Implement corrective actions to prevent recurrence.
- Execute product recall plans as required.
4) Procedure
4.1 Customer Complaint Handling
- Receive and acknowledge receipt of customer complaints.
- Record complaint details including product information, issue description, and contact information.
- Assign investigation team and initiate investigation.
4.2 Investigation and Root Cause Analysis
- Conduct thorough investigation to determine root cause(s) of complaint.
- Implement corrective actions to address identified root causes.
- Document investigation findings and actions taken.
4.3 Product Recall Initiation
- Evaluate complaint severity and impact on patient safety.
- Prepare and submit product recall initiation request.
- Implement recall plan including notification, retrieval, and disposal of affected products.
4.4 Closure and Documentation
- Close customer complaints after resolution and customer notification.
- Document all actions taken during complaint handling and recall process.
5) Abbreviations, if any
SOP: Standard Operating Procedure; QA: Quality Assurance; RA: Regulatory Affairs
6) Documents, if any
- Customer Complaint Form
- Investigation Report Template
- Product Recall Plan and Logs
7) Reference, if any
ICH Q10: Pharmaceutical Quality System
FDA Guidance for Industry: Handling Customer Complaints
8) SOP Version
Version 1.0