The List of Outsourced GxP Activities SOP 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: 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