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.