Case Study 34: EU GMP Qualification of a Sterile CMO in China for a French Biotech Firm
Client: A French biotech company developing biologics in sterile vials
Challenge:
The client identified a Chinese CMO with cost-effective sterile vial manufacturing capabilities. However, the facility lacked EU GMP certification, and the client needed to qualify it to expand into European markets.
Solution by Qualifyo:
Conducted a two-day on-site audit with a focus on sterile manufacturing, lyophilization processes, and environmental monitoring.
Guided the CMO in implementing a robust quality management system, including media fills and personnel training.
Assisted the client with the preparation of a technical agreement and EU GMP submission dossier.
Outcome:
The CMO achieved EU GMP compliance within eight months, allowing the client to enter European markets with cost-effective biologics.
The client saved 40% on manufacturing costs and avoided the high capital investment of building their own sterile facility.
Qualifyo’s expertise reduced the regulatory risk and ensured a smooth qualification process.
