With construction and plant commissioning complete, a leading biotech manufacturer set timelines to license its new facility and to pass all required inspections – State, FDA, and EMEA Pre Approval Inspections.

A gap analysis was performed, and action plans were developed to remediate or defend the identified gaps in the plant’s Quality System. Enterey provided project management support to the 14 departments throughout the plant and to the Director of Quality Assurance. In addition, Enterey provided the communication updates to Corporate Compliance and the GMP Core Team. Enterey also supported the staff during the inspections with defense strategies, documentation and final inspection room prep.

The facility was licensed per plan. The State, FDA and EMEA inspections were successful. There were no FDA observations. Observations issued by the State and EMEA were minor, and action plans to correct were implemented.