This SOP defines the process for selecting, qualifying, approving, and managing vendors, contractors, and service providers involved in GxP-related activities — including the sponsor’s oversight of outsourced functions.
 
It ensures that all third-party suppliers, CROs, and CMOs are evaluated and monitored according to defined quality, regulatory, and performance standards.
By implementing this procedure, biotech and life science companies can demonstrate full sponsor oversight and control of their outsourced operations — a key expectation during EMA and FDA inspections.
 
This SOP is professionally written, pre-filled, and 98–99 % complete, requiring only insertion of company-specific information (QA responsible, reviewer, vendor list).
It reflects GxP, ICH Q10, and ICH E6(R2) (GCP) requirements and supports both clinical and manufacturing outsourcing models.
 
Includes:
• Vendor identification and selection criteria
• Risk-based vendor qualification and approval process
• Documentation of technical and quality agreements
• Ongoing performance monitoring and requalification
• Sponsor oversight principles and QA responsibilities
• Audit, deviation, and CAPA requirements for suppliers
 
This template provides the structure and documentation flow necessary to ensure that every vendor relationship — from CRO to CMO — is controlled, traceable, and compliant.
It’s a critical SOP for biotech companies relying on outsourcing to achieve compliance and maintain inspection readiness.