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.
SOP 4.2 List of outsourced GxP activities
Consulting Support
If you prefer expert guidance, OZQA provide QA Services, such as:
- GxP compliance (GMP and GDP)
- ISO 9001 and ISO 13485 quality systems
- QMS structure and implementation
- SOP development and process documentation
- Deviation, CAPA, Change Control, and OOS processes
- Audit and inspection preparation
- Oversight of outsourced partners
Product Details & Purchase Terms
You will receive:
- Downloadable Word files (.docx)
- ~98% pre-filled templates
- Immediate access after purchase
Important:
- No refunds (digital product)
- Requires customization