QMS SOP Template: Product Quality Complaints

Published: July 2025
Pages: 16

• Special Pricing for Emerging Economies

Effective complaint handling is critical for maintaining product integrity, safeguarding patient safety, and driving continual improvement.

This Standard Operating Procedure (SOP) includes a template that helps the user outline the process for receiving, documenting, evaluating, and resolving product quality complaints within the pharmaceutical organization. The purpose of the SOP is to ensure that all reported product quality issues are managed in a consistent, timely, and compliant manner in alignment with applicable regulatory requirements, such as the US Food and Drug Administration (FDA) 21 CFR, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.