Case Study 25: Multi-Country API Supplier Qualification for a German Pharma Giant
Client: A leading German pharmaceutical company with an extensive global API supply chain
Challenge:
The client needed to audit 12 API manufacturing sites across India, China, Japan, and Italy as part of their annual supplier qualification plan. Managing audits across multiple countries and time zones while ensuring consistency in audit reporting was a logistical challenge.
Solution by Qualifyo:
- Assigned a dedicated project manager to coordinate the entire audit process across all regions.
- Mobilized local auditors in each country to conduct on-site audits, ensuring compliance with EU GMP standards and client-specific requirements.
- Standardized audit protocols and reporting formats to maintain consistency and simplify supplier comparisons.
- Provided a centralized dashboard for the client to track audit progress, findings, and corrective actions in real-time.
Outcome:
- All 12 audits were completed within six months, meeting the client’s annual qualification timeline.
- The client saved 40% on audit-related costs by avoiding the need to hire multiple service providers or deploy internal audit teams.
- Centralized project management eliminated logistical bottlenecks and streamlined communication.
