Case Study 36: Qualification of a Sterile Injectable CMO in India for a Spanish Pharma Company
Client: A Spanish pharmaceutical company specializing in sterile ophthalmic products
Challenge:
The client identified a sterile injectable CMO in India with attractive pricing but lacked EU GMP certification. The client needed to ensure compliance while minimizing costs.
Solution by Qualifyo:
Conducted a risk-based audit, focusing on aseptic filling, sterilization validation, and environmental monitoring.
Partnered with the CMO to develop a CAPA plan and implement EU GMP-compliant practices.
Assisted the client in preparing the regulatory submission for EMA approval.
Outcome:
The CMO achieved EU GMP compliance within eight months, allowing the client to launch their ophthalmic product in Europe.
The client reduced manufacturing costs by 25%, ensuring a competitive price for their product.
The streamlined qualification process saved the client 30% in costs compared to hiring multiple third-party auditors.
