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.
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)
