Case Study 37: EU GMP Qualification of an OSD and Sterile CMO in India for a Belgian Pharma Company
Client: A Belgian pharmaceutical company expanding its generics portfolio
Challenge:
The client needed to qualify an Indian CMO for both OSD and sterile drug formulations. The CMO offered competitive pricing but lacked EU GMP certification for both product lines.
Solution by Qualifyo:
Conducted parallel audits for OSD and sterile manufacturing operations, identifying critical gaps in facility and HVAC systems.
Worked with the CMO to upgrade their facility and quality systems, including cleaning validation, HVAC system qualification, and personnel training.
Provided post-audit support to the CMO to address findings and prepare for EU GMP certification inspections.
Outcome:
The client successfully qualified the CMO for both OSD and sterile products within nine months without shifting a single product outside the facility.
Manufacturing costs were reduced by 40% compared to EU-based CMOs, providing significant long-term savings.
The client avoided the complexity of engaging separate consultants for each product line by using Qualifyo’s integrated services.
