The List of Outsourced GxP Activities template provides a controlled record of all contracted activities performed by external vendors, CROs, or CMOs that fall under GxP requirements.
It ensures that all outsourced processes are clearly identified, risk-assessed, and covered by appropriate technical or quality agreements.
 
This document is pre-filled and 99% complete, serving as a living, inspection-ready record for vendor oversight in both clinical and manufacturing environments.

It aligns with ICH and GMP expectations for sponsor accountability.
 
Includes:
Vendor name, service type, and GxP classification
Scope of outsourced activity
Reference to quality and technical agreements
Responsible QA contact and review status
Change and re-approval log
 
Maintaining this list demonstrates clear sponsor oversight and ensures that all critical suppliers are qualified, documented, and under active quality control.