The Product Complaints SOP establishes a standardized process for receiving, documenting, investigating, and responding to product-related complaints.
It ensures that all reported issues are handled transparently and that necessary corrective actions are taken promptly.
This SOP is 99 % complete and ready for use, fully aligned with GxP, ICH, and EMA/FDA complaint-handling requirements.
Includes:
•Complaint intake, registration, and categorization
•Investigation procedures and QA review
•Root-cause determination and CAPA linkage
•Communication with customers, sponsors, and authorities
•Documentation and trending of complaint data
Implementing this SOP strengthens quality oversight, supports pharmacovigilance, and demonstrates commitment to continuous improvement.