Case Study 32: Qualification of a Sterile Injectable CMO in India for a UK Pharma SME
Client: A UK-based SME specializing in generic sterile injectables
Challenge:
The client identified a cost-effective Indian sterile injectable CMO that lacked EU GMP certification. They needed to qualify the facility for EMA compliance to proceed with their product launch but had limited resources for regulatory consulting and audit management.
Solution by Qualifyo:
Conducted a comprehensive pre-audit gap assessment remotely, identifying key areas where the CMO fell short of EU GMP standards.
Performed a detailed on-site audit, focusing on sterile area validation, environmental monitoring, and aseptic process controls.
Provided hands-on guidance to the CMO for preparing an EU GMP dossier, addressing audit findings, and implementing corrective actions.
Outcome:
The CMO achieved compliance with EU GMP within six months, enabling the client to proceed with their product registration.
The client is successful in registering critical products on time and also saves 40% in qualification-related expenses by leveraging Qualifyo’s expertise instead of engaging multiple consultants.
The partnership with the CMO resulted in a 30% reduction in manufacturing costs compared to EU-based CMOs.
