Case Study 1: Comprehensive GMP Audit for a European API Manufacturer
Client: A leading pharmaceutical company in Germany
Challenge
The client required a third-party audit of their primary API supplier located in India to ensure compliance with EU GMP standards. Their internal audit team lacked the capacity and expertise for an on-site inspection in Asia, which risked delaying product approvals
Solution by Qualifyo:
- Assigned a team of experienced EU GMP-certified auditors with expertise in API manufacturing.
- Conducted a two-day on-site audit of the supplier’s manufacturing facility.
- Performed a thorough assessment of quality systems, facility design, process controls, and documentation.
- Identified critical gaps in the supplier’s cleaning validation and CAPA implementation.
Outcome:
- Delivered a detailed audit report within 7 business days, including a prioritized list of corrective actions.
- Collaborated with the supplier to close critical gaps within 30 days, ensuring compliance.
The client successfully renewed their EU GMP certification, avoiding disruption in API supply.
