EU GMP Assistance for Pharmaceutical Manufacturer in Vietnam

October 16, 2023
by SeerPharma

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.

GMP Isolator with vials

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.

Filed Under: GMP, EU GMP, Vietnam