Case Study 9: Emergency Compliance Audit for a German API Importer
Client: A German importer of APIs supplying finished dosage manufacturers across Europe
Challenge:
The client faced a regulatory warning due to the lack of a recent GMP audit for one of their key suppliers in India. An urgent audit was required to prevent import suspension.
Solution by Qualifyo:
- Arranged a qualified auditor within 48 hours, leveraging Qualifyo’s extensive network of local experts.
- Conducted a one-day compliance-focused audit, emphasizing critical areas such as batch traceability and quality system management.
- Provided a real-time preliminary report, enabling the client to submit immediate updates to the regulator.
Outcome:
- The client avoided supply chain disruptions by promptly addressing regulatory concerns.
- The supplier implemented corrective actions based on Qualifyo’s audit findings within 2 weeks.
- The client saved 35% in costs compared to flying in auditors from Germany for the emergency audit.
