Case Study 14: Qualification of a Sterile API Manufacturer for a Swiss Biotech Firm
Client: A Swiss biotech company focused on high-potency APIs
Challenge:
The client needed to qualify a sterile API manufacturer in India to ensure compliance with EU GMP and alignment with specific handling requirements for high-potency APIs.
Solution by Qualifyo:
- Conducted a two-day on-site audit, focusing on facility design, containment controls, and sterility assurance.
- Evaluated the supplier’s cleaning validation protocols and microbiological testing capabilities.
- Provided real-time corrective guidance to address non-conformities in HVAC and aseptic areas.
Outcome:
- The supplier addressed all major non-conformities within 45 days, ensuring compliance.
- The client onboarded the supplier, securing a reliable source for sterile high-potency APIs.
- Qualifyo’s local expertise reduced audit-related travel and logistics costs by 30%.
