finished drug product / nonsterile product / manufacturing facility / aseptic processing facilities / aseptic processing / sterile drug products / biological products / adjunct processing / sterile drug manufacturing facility / final product / bulk processing steps / aseptic processing line / exposed sterilized product / work site / sterilized drug product / drug product / aseptic processing zones / Cell-based therapy products / sterile drug applications / control systems / aseptic manufacturing processes / designed air handling systems / filtration systems / rubber closures / in-process product / manufacturing practice / aseptic processing operation / drug products / aseptic processing facility monitoring program / qualified systems / provided regarding upstream bulk processing steps / be manufactured using aseptic processing / /
MedicalCondition
sterility / product sterility / /
Organization
U.S. Department of Health and Human Services / Training and Communication Division of Drug Information / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / office of Compliance / office of Regulatory Affairs / office of Training / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / HFD-240 Center for Drug Evaluation and Research / office of Communication / Training and Manufacturers Assistance / /
Person
Robert Coleman / Richard Friedman / Robert Sausville / / /
Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.