Expert Working Group / B. Cell Bank Maintenance / Validated Systems / Record Keeping / D. Computerized Systems / APIs / /
Country
Japan / United States / /
Event
Product Recall / Product Issues / /
Facility
LABORATORY CONTROLS / Laboratory Control Records / Rockville Pike / / /
IndustryTerm
cell bank / aseptic processing / chemical synthesis / extraction processing / investigational medicinal products / fermentation/ cell culture master cell cell bank fermentation / drug product / chemical properties / term manufacturing / bank bank fermentation purification packaging / manufacturing steps / manufacturing practices / Physical processing / manufacturing / manufacturing practice / active pharmaceutical ingredients / purification packaging bank / /
MedicalTreatment
gene therapy / /
Organization
U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / office of Training / Training and Communications Division of Communications Management Drug Information Branch / FDA / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / ICH Steering Committee / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / Quality Unit / office of Communication / Training and Manufacturers Assistance / / /
Position
A. General / General / /
Product
G. Handling of Complaints / /
Technology
gene therapy / Biotechnology / API / radiopharmaceuticals / /
Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients U.S. Department of Health and Human Services