Case Study 15: Rapid Qualification of a PM Supplier for a German Packaging Solutions Company
Client: A German company providing specialized pharmaceutical packaging solutions
Challenge:
The client sought to qualify an Indian PM supplier for primary packaging materials critical for sterile drug products. Ensuring compliance with EU regulations for materials in direct contact with sterile drugs was crucial.
Solution by Qualifyo:
- Conducted a one-day audit focusing on material specifications, traceability, and packaging integrity testing.
- Assessed compliance with EU requirements for leachables and extractables studies.
- Worked closely with the supplier to align their testing protocols with client and regulatory expectations.
Outcome:
- The supplier achieved qualification within 15 days, enabling the client to meet their project deadlines.
- The client gained a cost-effective and compliant supplier for sterile packaging materials.
- Qualifyo’s efficient processes saved the client 25% in audit expenses.
