Workshop for Licensing Blood Establishments |
Contents
The Managed Review Process | 5 |
General Requirements for Establishment License Applications | 13 |
Cooperative Manufacturing AgreementsContract Manufacturing | 21 |
27 other sections not shown
Common terms and phrases
Antibody anticoagulant approved AS-1 RED BLOOD autologous automated Biologics Evaluation Blood and Blood Blood Banks BLOOD CELLS DIVIDED Blood Components blood donations Blood Establishments CBER CELLS DIVIDED IRRADIATED CELLS DIVIDED Pt Center for Biologics circular of information container CP2D CPD RED BLOOD CPDA-1 RED BLOOD Cryoprecipitated Cryoprecipitated AHF dating period deferral DEGLYCEROLIZED DEPARTMENT OF HEALTH DIVIDED IRRADIATED Pt donation donor suitability Evaluation and Research expiration date Federal Regulations FOOD AND DRUG form FDA FRESH FROZEN PLASMA graft-versus-host disease Guideline GVHD HBsAg Health Service Act HEALTH SERVICE FOOD HUMAN SERVICES PUBLIC informed consent irradiated blood products Labeling of Blood laboratory LEUKOCYTES REMOVED Lot number manufacturer's performed Pheresis plasmapheresis plateletpheresis Platelets pooled Public Health Service quality control records RED BLOOD CELLS responsible head samples SERVICES PUBLIC HEALTH Source Leukocytes Source Plasma STCD Storage Temperature submitted supplement syphilis testing Title 21 transfusion Uniform Labeling units venipuncture volume ZIP CODE