Case Study 19: Qualification of an OSD CMO for a US-Based Pharma Startup
Client: A US-based pharmaceutical startup specializing in niche OSD formulations
Challenge:
The client needed to qualify an Indian OSD CMO to scale up production for a newly developed formulation. Budgetary limitations and tight timelines posed a significant challenge.
Solution by Qualifyo:
- Conducted a hybrid audit approach: an initial remote documentation review followed by an on-site audit conducted by a local auditor in India.
- Focused on evaluating batch records, cleaning validation, and cross-contamination controls in the OSD facility.
- Collaborated with the CMO to implement a simplified CAPA process to address minor non-conformities.
Outcome:
- Supplier qualification was completed within 30 days, enabling the client to scale up production on time.
- The client saved 40% in audit-related costs by leveraging Qualifyo’s hybrid audit model and local expertise.
- The client established a strong partnership with the CMO, ensuring cost-effective production of their product.
