Case Study 4: Mitigating Supply Chain Risks for a US-Based Generic Drug Manufacturer
Client: A generic drug manufacturer with global operations
Challenge:
The client faced regulatory pressure due to recurring non-compliances observed in their primary excipient supplier based in Southeast Asia. They needed an independent third-party audit to address compliance gaps and avoid supply disruptions.
Solution by Qualifyo:
- Conducted a detailed root cause analysis of past non-compliances.
- Performed a two-day on-site audit, focusing on supplier’s QMS, traceability, and batch testing protocols.
- Provided real-time consulting to the supplier during the audit to address immediate deficiencies.
- Delivered a tailored compliance roadmap to close non-conformities.
Outcome:
- The supplier successfully implemented the corrective and preventive actions within 60 days.
- The client avoided a potential product recall and restored regulatory confidence.
Supply chain risks were mitigated, ensuring uninterrupted product availability in the market.
