Case Study 20: Multiple API Audits for a German Pharmaceutical Company
Client: A large German pharmaceutical company sourcing APIs for its generics portfolio
Challenge:
The client needed to conduct back-to-back audits of four API manufacturing sites in India. Conducting multiple audits with their internal team would have significantly increased costs due to travel and extended timelines.
Solution by Qualifyo:
- Deployed four local auditors with expertise in API GMP compliance and EU regulations, enabling simultaneous audits.
- Evaluated process controls, equipment qualification, and data integrity practices at all sites.
- Delivered standardized reports with comparative assessments to help the client make informed supplier selection decisions.
Outcome:
- All audits were completed in just two weeks, reducing the qualification timeline by 50%.
- The client saved 60% in costs compared to sending an internal team from Germany for the audits.
- The client onboarded two compliant suppliers, securing cost-efficient and high-quality APIs for their portfolio.
