RT Journal Article SR Electronic T1 Results of a Survey of Biological Drug and Device Industries Inspected by FDA under the Team Biologics Program JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 211 OP 222 VO 61 IS 3 A1 Steve Buchholz A1 Victor J. Gangi A1 Anne Johnson A1 Jacqueline Little A1 Steven Mendivil A1 Carolyn Trott A1 Keith Webber A1 Mark Weinstein YR 2007 UL http://journal.pda.org/content/61/3/211.abstract AB The Product Quality Research Institute, in conjunction with the Food and Drug Administration, conducted an anonymous, electronic survey of the biological products manufacturing industry inspected by Team Biologics, with emphasis in obtaining industry input on inspection and compliance aspects of program operations. Representatives from all of the product-specific manufacturing industries inspected under the Team Biologics Program responded to this survey (vaccines; fractionated plasma proteins and recombinant analogs; allergenics; therapeutics and in-vivo diagnostics; and in-vitro diagnostics, including blood grouping reagents). Data and written feedback was obtained regarding each firm’s interactions and experiences of Team Biologics inspections at its facilities over the past three years. The three areas most impacted by Team Biologic inspections were “Production and Process Controls”, “Failure Investigations” and “Facility / Equipment Controls”. Overall assessment of the program was generally positive with 68% identifying a positive impact on the sites operations and 88% assessed the inspections as being conducted fairly. The findings and conclusions of this report will be utilized by the FDA to evaluate and further assess the impact of the Team Biologics Program and to implement any necessary changes. This report provides useful information to companies currently manufacturing licensed biologic products subject to Team Biologics inspections and also to those companies anticipating these inspections for future product manufacturing.