Case Study 38: Qualification of a Sterile Injectable CMO in Turkey for a Dutch Pharmaceutical Company
Client: A Dutch pharmaceutical company expanding its sterile product portfolio
Challenge:
The client wanted to qualify a Turkish sterile injectable CMO that offered competitive pricing but had no prior EU GMP certification.
Solution by Qualifyo:
Conducted a comprehensive audit focusing on sterile filling, environmental monitoring, and microbiological testing.
Assisted the CMO in developing a CAPA plan and upgrading their quality system to meet EU GMP standards.
Provided training sessions for the CMO’s personnel on EU GMP requirements.
Outcome:
The CMO achieved EU GMP compliance within 10 months, enabling the client to proceed with product registration.
The client reduced manufacturing costs by 35% while maintaining compliance with EU regulatory standards.
Qualifyo’s single-window solution eliminated the need to hire multiple service providers, reducing qualification expenses by 30%.
