Case Study 7: Multi-Site Supplier Audit for a UK Generics Manufacturer
Client: A leading generics pharmaceutical company in the UK
Challenge:
The client required simultaneous qualification audits for three API suppliers in different regions of India to diversify their supply chain. Conducting multiple audits using an internal team would have incurred significant time and cost.
Solution by Qualifyo:
- Allocated three experienced auditors from India, each specialized in API manufacturing and EU GMP requirements.
- Conducted audits concurrently at all three locations, covering key areas like documentation integrity, facility hygiene, and process validation.
- Compiled a comparative summary report to help the client evaluate supplier performance and compliance levels.
Outcome:
- The client completed supplier qualification for all three suppliers within 4 weeks, compared to the estimated 8 weeks using internal resources.
- Saved 50% in costs by leveraging local auditors and avoiding international travel expenses.
- Strengthened their supply chain by onboarding two compliant suppliers for long-term contracts.
