Challenge

A mid-sized biotech required an OEL-4-compliant Indian CDMO for a potent oncology API. The site claimed high containment, but:
• No documented SMEPAC data
• Incomplete cleaning validation
• Missing operator exposure assessments
• Quality procedures not aligned with USFDA expectations
Sponsor needed independent verification before awarding the project.

The Intervention

• Conducted on-site containment audit (QMS, engineering, PPE, air-handling, controls)
• Recommended corrective and preventive actions (CAPAs)
• Implemented containment verification (airflow, pressure mapping, SMEPAC guidance)
• Trained site PM/QC teams on USFDA-ready documentation
• Developed an inspection readiness roadmap with timelines

Outcome

• Facility achieved documentation and operational readiness within 90 days
• USFDA audit completed successfully with no major observations related to containment
• Sponsor-approved CDMO for multi-year supply

Impact

A potentially risky manufacturing site became inspection-ready and compliant.

Why Aventiq Bio

The methodology for a repeatable vendor evaluation and risk mitigation framework for outsourcing to Indian CROs/CDMOs.