Case Study 11: End-to-End Qualification of a Sterile CMO for a Belgian Pharmaceutical Company
Client: A mid-sized pharmaceutical company in Belgium focused on sterile injectables
Challenge:
The client needed to qualify a sterile CMO in India for their injectable drug product. Ensuring compliance with EU GMP Annex 1 for sterile manufacturing was critical for regulatory approvals.
Solution by Qualifyo:
- Conducted a pre-audit risk assessment, focusing on sterile area classification, aseptic practices, and environmental monitoring.
- Performed a three-day on-site audit, evaluating sterility assurance, operator training, and media fill studies.
- Provided detailed feedback on cleanroom practices and helped the CMO strengthen their contamination control strategy.
Outcome:
- The CMO successfully implemented CAPA within 30 days, ensuring full compliance with EU GMP Annex 1.
- The client gained confidence in the CMO’s capabilities and secured regulatory approvals for their sterile product.
