New Facility Preparation for Pre-Approval Inspection PHARMACEUTICAL INDUSTRY Client A large pharmaceutical company contracted with a new Korean biologics Contract Manufacturing Organization (CMO) facility to manufacture their products. Problem Biologics is a new core business for the parent company of a new Biologics CMO that has not been inspected by a regulatory agency, the majority of the workforce consisted of inexperienced recent Korean college graduates (other than ~100 expats) who needed to be trained and coached on how to manage an inspection as well as ensure all the elements anticipated for review are inspection ready. Approach Tunnell’s responsibilities included: Coordinating all consultant resources on behalf of the client at the Korean CMO site. Developing a plan of activities based on assessed areas of anticipated inspection. Evaluating success risks and closing the gaps, which included: Driving deviation, investigation and CAPA resolutions to closure Assisting site leads with preparation of briefing documents and other typically requested documentation Assisting with inspection site logistics and coaching subject matter experts on how to respond to investigators questions Observing and coaching mainly Korean operators where English was a second language Results A successful FDA inspection resulted in no observations and only minor recommendations. There was an additional successful European Union Agency inspection with a few major and minor observations that were anticipated due to the immaturity of the systems and workforce. A culture of continuous improvement and optimization was achieved along with a definitive understanding what it means to be “inspection ready” at all times. PT-39