Case Study 24: Large-Scale API Supplier Audit for a Scandinavian Biopharma Company
Client: A Scandinavian biopharma company specializing in rare diseases Challenge:
Challenge:
The client needed to audit a large API supplier in India with a complex supply chain. Budget constraints required a cost-efficient solution without compromising audit quality.
Solution by Qualifyo:
- Assigned a senior local auditor with expertise in supply chain management and API GMP compliance.
- Conducted a detailed two-day audit, focusing on raw material sourcing, batch traceability, and quality control.
- Provided tailored recommendations to improve supply chain transparency and strengthen compliance.
Outcome:
- The supplier was qualified within 30 days, ensuring uninterrupted API supply for the client’s rare disease treatments.
- The client saved 35% in audit costs compared to engaging a global audit firm.
- Enhanced supplier compliance reduced the risk of supply chain disruptions.
