Services

Design Review

ServicesNew FacilitiesDesign Review

The key target of the design review is to evaluate all aspects in the design which could potentially affect the final product and to review the GMP compliance at the very early stage for a new planned facility. This helps right in time avoiding deficiencies or potential quality risks at the beginning of the project.

With the GMP expert perspective, and through a systematic review of the design drawings at the different stages, e.g., conceptual design, basic design and detailed design, gempex digs into all the design drawings to identify GMP compliance issues and offers improvement suggestions and alternatives plan if any to ensure the new set up plant, upgrading and reconstruction projects are in compliance with the GMP requiremnts. At the same time, gempex specially puts the focus on the potential risks analysis for contamination and cross-contamination for products.

Service Advantage

Technical expert team in international multi-fields: engineering, pharmaceutical/ biomedical backgrounds

Over ten new factories design review projects every year: covering vaccine, antibody, preparation and other types of enterprises

Professional design review report with improvement suggestions (Language options Chinese/English/German available)

advantage

The Drawing Review Includes but Not Limited to

1. Conceptual design (CD), Basic Design (BD) and Detailed Design (DD) phases
2. Review and analysis varies per each phase, and contentsincludes but not limited to

  • Project plan
  • Process layouts
  • Floor layouts
  • Equipment layouts
  • Personnel and materials flows
  • Differential pressure concept
  • HAVC P&ID
  • HVAC duck system layouts
  • Monitoring plan
  • Utilities and other special considerations

Service Workflow