《TEAM BIOLOGICS INSPECTION APPROACH - PDA May 2016》.ppt

TEAM BIOLOGICS INSPECTION APPROACH Ann Marie Montemurro, Supervisory CSO FDA / ORA / ORO Team Biologics Core Team Objective Provide a brief overview of the Team Biologics program Outline the Team Biologics inspection approach under Compliance Program 7345.848 Team Biologics - Who Are We? Team Biologics is a partnership between ORA and CBER Established in 1997 Focus on ensuring the quality and safety of biologic products Assure consistent comprehensive inspections of biologics manufacturers Core Team Includes specially trained field investigators: Rose Ashley Omotunde Osunsanmi Jacqueline Diaz-Albertini Prabhu Raju Cynthia Jim Helen Ricalde Mihaly Ligmond Paula Trost Christian Lynch Supervisor: Ann Marie Montemurro Also includes: CBER product specialists, ORA and CBER compliance officers, and respective management What Do We Do? Responsible for conducting post-market inspections of licensed biologic drugs and devices including: Vaccines Allergenic extracts products Antitoxins, antivenins, and venoms Plasma derived products, including their recombinant analogues Licensed IVD products Gene / Cellular Therapy Products Note: In 10/2007 the inspection responsibility for CDER regulated licensed therapeutic products was transferred from Team Biologics to the District Offices Inventory of Firms 28 Vaccines and Related Products 42 Plasma derived products and their recombinant analogues 15 Allergenic Extracts 26 IVD 1 Cell Therapy Includes both domestic and foreign sites Team Biologics Inspections TB post-approval inspections led by ORA biennial GMP Directed / Compliance Follow-up inspections – may be more frequent Inspection Team ORA CT Investigator(s) Center Product Specialists Participation on-site or via telephone May Include district participation Can be conducted jointly with CBER/DMPQ pre-approval inspection Systems Based Inspections Utilize a risk-based approach to conducting inspections which identifies six key systems and three critical elements w