EU GMP Assistance for Pharmaceutical Manufacturer in Vietnam

A leading pharmaceutical manufacturer in Vietnam requested SeerPharma to conduct an on-site review of a manufacturing line, in preparation for an impending European Union (EU) Good Manufacturing Practice (GMP) inspection.

SeerPharma spent time on site conducting a GMP review of a line that incorporated a closed Restricted Access Barrier System (cRABS) with Lyophiliser.

The review of the manufacturing line, saw SeerPharma focus on:

• Hardware and software dossiers
• Equipment qualification
• Systemic review of all components of equipment qualification dossiers of the closed RABS
• Validation protocols and reports
• All relevant documentation for an impending EU GMP Inspection

A separate team from SeerPharma will conduct a full mock EU GMP Inspection in final preparation for the eventual audit.

Contact us to leverage our services in preparing for EU GMP Inspections in the Asia-Pacific region.