The Evaluation and Approval of GxP Vendors SOP defines the standardized process for assessing, approving, and maintaining qualified vendors that perform GxP-relevant activities.

It ensures consistent vendor oversight and compliance with ICH Q10, GMP, GCP, and GDP expectations.
 
This SOP is professionally written and pre-filled (≈ 99% complete), requiring only company name and QA responsible to finalize.
It supports biotech and life science organizations in establishing full traceability and risk-based control of outsourced operations — a critical requirement during EMA and FDA inspections.
 
Includes:
Vendor pre-assessment and qualification process
Risk evaluation and approval criteria
Documentation and QA approval workflow
Ongoing monitoring and requalification procedures
Integration with vendor audit and CAPA systems
 
This SOP enables companies to demonstrate full control of external suppliers, ensuring product quality, data integrity, and regulatory compliance across all GxP activities.