Case Study 28: High-Volume API Supplier Audits for a UK-Based Multinational Pharma Company
Client: A UK-based multinational pharmaceutical company with a diverse API supplier base
Challenge:
The client needed to audit 20 API manufacturing sites across India, China and Japan. The audits had to be completed within nine months to comply with their internal quality systems and regulatory commitments.
Solution by Qualifyo:
- Deployed a large team of auditors with expertise in APIs and regional GMP standards.
- Assigned a dedicated project manager to oversee scheduling, auditor deployment, and reporting.
- Used Qualifyo’s audit tracking platform to provide real-time updates on audit progress and supplier CAPA implementation.
Outcome:
- The client met their regulatory commitments, qualifying all 20 suppliers within the required timeline.
- By leveraging Qualifyo’s extensive auditor network, the client saved 45% on audit-related expenses.
- Centralized project management reduced the administrative burden and improved audit oversight.
