Applied News

Author: Kristen Cif

What is a QCU?

September 18, 2013 by Kristen Cif

The FDA requires each firm to establish a quality control unit (QCU). The QCU has the responsibility and authority to approve or reject all drug product containers, closures, in-process materials, labeling, written procedures, the authority to review production records to assure completeness and accuracy, and is responsible for the approval or rejection of all manufactured drug products. The responsibilities and procedures applicable to the QCU must be in writing and must be followed. The designated person(s) are required to meet the Personnel Qualification requirements [211.25], must be identified in the firms procedures, and must receive appropriate quality assurance training. This includes training in the particular operations that the employee performs and in current good manufacturing practice as it relates to the employees functions. A small firm may designate a single individual with the personnel qualifications. QCU managers and personnel can get the training they need fast

Posted in QCU

Recommended Products

Applied Inside
What's New?
Categories
OxyGo (17)General (11)Oxygencylinders (9) (8)Oxygen (8)OxySafe (8)OSHA (7)DOT (6)Cylinders (6)POC (6)FDA (5)Deliveringoxygen (5)Servomex (5)GHS (4)Medicaloxygen (4)Fillingoxygen (4)Leaktesting (3)CGMP (3)Tips And Tricks (2)Transfilling (2)Carriers (2)Competitivebidding (2)Seminars (2)Liquidtogas (2)Portableoxygenconcentrator (2)Brassandvitonwashers (2)Cannula (2)Valves (2)Oxygen Safety (2)Trainingaids (2)Nosmokingsigns (2)Oxygensafety (2)Training (2)Labels (2)Medtrade (2)Pigtails (2)Gastogas (2)refillingoxygencylinders (1)Driverdailylogbook (1)Oxygensaturation (1)Pulserate (1)gastogas (1)Fingertip (1)Oximeter (1)liquidtogas (1)Oxygencleaning (1)oxygenprofits (1)Labelupdate (1)Servicearea (1)Deliverybusinessmodel (1)profit (1)planning (1)budget (1)business (1)Oxygencompressedlabels (1)Oxygentraining (1)Oxygenlabels (1)Disinfectingoxygenequipment (1)Cleaningequipment (1)DOTtraining (1)FDAtraining (1)Employeetraining (1)Comparisonchart (1)Regulatoryrequirements (1)Investment (1)Oxygenfires (1)AppliedCertifiedOxygenQualityControl (1)AppliedCertifiedOxygenSpecialist (1)AppliedCertifiedOxygenDriver (1)AppliedCertifiedOxygenTransfiller (1)OxygenSpecialistProgram (1)Disposablerespirator (1)Isolationkits (1)Cylinder (1)Cleanerdisinfectant (1)Singlelumenconserver (1)Thermalshutoffdevice (1)OxyPulse (1)Oxygenconserver (1)USDOT (1)AppliedCertifiedOxygenFillingBusiness (1)CGA870 (1)Privatebranding (1)Conservers (1)Cannulafires (1)Medtradeseminar (1)LiquidtoGas (1)DMEcompanies (1)Costreduction (1)Non Deliverymodel (1)Oxygendeliveryarea (1)CGA540 (1)Testingregulators (1)Medicaloxygenregulator (1)Hazardousmaterial (1)Warehousesignage (1)Cylindervalveconnections (1)Threadedvalveconnections (1)Postvalveconnections (1)Refillingyouroxygencylinders (1)Shipping Papers (1)FDAregistration (1)Medtrade Spring 2016 (1)Issue 3 (1)Home HealthCare Today (1)Oxygen Expenses (1)Oxygen Costs (1)Competitive Bidding (1)Smoking Cigarettes (1)Oxygen 101 (1)Analyzer (1)Amazon Gift Card (1)Oxystat (1)Non Delivery Model (1)Warranty (1)continuingtraining (1)DOTseminar (1)MedtradeFall2015 (1)rebateoffer (1)2016 (1)Portable Oxygen Concentrator (1)oxygenanalyzers (1)Trade Show (1)PatientStories (1)DMEs (1)IndustryNews (1)Travel (1)POCs (1)AppliedUniversity (1)Industry News (1)OxyCareAdvantage (1)OxyHome (1)Financing (1)Smart Delivery (1)Bi Directional (1)Nebulizers (1)Nuvo (1)SOC (1)Concentrator (1)handheldanalyzer (1)Compressed USP (1)transfilling (1)HBS (1)Connections (1)NPT (1)Quickconnectors (1)Improvingbusiness (1)Hiringemployees (1)medicaloxygen (1)oxygen (1)harvardbusinessschoolaward (1)DOTfines (1)portableoxygenconcentrator (1)oxygenlabels (1)FDAguidance (1)LeakDetectionSolution (1)Supplytubing (1)Oxygo (1)fillingoxygen (1)oxygendelivery (1)driverdeliveryvehicles (1)Compliant Labels (1)Westlake (1)Cylinder Labels (1)Misbranding Medical Oxygen (1)Job (1)Wantedad (1)Salesrepresentative (1)Westlakeinbloom2015 (1)Teamwork (1)Employees (1)Drivers (1)Corporatechallenge (1)Boxes (1)Bags (1)Racks (1)Carts (1)Compressedgascylinders (1)Warehousepersonnel (1)Respiratorytherapists (1)oxygencylinders (1)Trainingworkbooks (1)Batchproductionrecords (1)regulatoryrequirements (1)FDAandDOTrequirementsforcylinderstorage (1)minioxygenstorageaudit (1)GHS symbols for oxygen labels (1)GHS and OSHA (1)OSHA requirements for oxygen cylinder labels (1)oxygen cylinder labels (1)oxygensystems (1)Fdacgmptraining (1)conservers (1)makingmoney (1)competitivebidding (1)transportingcylinderssafely (1)cylindercarriers (1)cylinderbags (1)Oxygentrainingbypersonnel (1)ISO8359 (1)cylindercarts (1)Accreditationrequirements (1)CPAPtubing (1)CGAconnections (1)Liquidgases (1)Cryogenichoses (1)Transfillingsiterequirements (1)Vehiclerequirements (1)Oxygencertified (1)Oxygenconcentrators (1)Nitrogencertified (1)Paramagneticoxygenanalyzers (1)Oxigraf (1)Calibratingoxygenanalyzers (1)Calibrationgases (1)Specifiedgases (1)ISOstandards (1)cylinderracks (1)CPAP (1)ResMedS9 (1)SDS (1)calibration gases (1)oxygen analyzer (1)VA (1)Patient Safety (1)Product Reviews (1)Patient Bags (1)NIST Standards (1)SOP (1)Thermometer (1)High Pressure Gauges (1)Calibration (1)QCU (1)Better Oxygen Business (1)System (1)Supplying Medical Oxygen (1)Oxygraf analyzer (1)FDA Compliant Drug Product Labels (1)buyingoxygeninbulk (1)filling cylinders (1)fillingoxygencylinders (1)medicaloxygenandcuttingcosts (1)DME (1)increasingprofitsformedicaloxygen (1)transfillingmedicaloxygen (1)filling oxygen (1)DUNs number (1)New labeling and Hazcom training requirements (1)transferring oxygen (1)FDA registration (1)required training (1)employee training (1)Job specific training (1)DOT training (1)FDA training (1)Medicaltubing (1)Signageforoxygendistributors (1)Lotstickers (1)OxygenEquipmentCleaner (1)LiquidtoGastransfillsystem (1)MedtradeFall2014 (1)Cylinderracks (1)DOTvehiclerequirements (1)Oxygenvehicles (1)CleanerDisinfectant (1)ConcentratorCleaner (1)Cartsandracks (1)3GLabelRemover (1)Oxygensupplier (1)Analyzermaintenance (1)OxygenUSP (1)Paramagneticoxygenanalyzer (1)Inhousetraining (1)Rattle Lessracks (1)Oxygenfilling (1)OxyLok (1)Transfilling Oxygen (1)Fillingaccessories (1)Fillingparts (1)Cuttingoxygencosts (1)Gastogassystem (1)Liquidtogassystem (1)Drug Listing (1)FDA Registration (1)Cylinderbags (1)OxyFillLiquidtoGasOxygenRefillingSystem (1)OxyFillGastoGasRefillingSystem (1)FederalLawoncGMP (1)DOTinPlainEnglish (1)CGA (1)Regulators (1)Cylindercarts (1)Employeetrainingformedicaloxygen (1)Valveseals (1)Signageforoxygenmanufacturers (1)Monarch (1)Thermometercalibration (1)Gaugecalibration (1)Equipmentcalibration (1)ExpirationDate (1)Lot (1)LabelGun (1)OxyMark (1)Pigtailinspectionform (1)2014OxygenSeminar (1)AccreditationSeminar (1)Leaktestingsolution (1)Onlineclassinstructions (1)Accessingonlineclasses (1)AppliedUniversityWalkthroughvideo (1)communityservicedaysatApplied (1)Calibrationchart (1)Oxygentransfillingsystem (1)Medicaloxygencylinders (1)Oxygen Delivery (1)Cylindershoulders (1)Regulator (1)Cylindervalve (1)Plasticwashers (1)Nylonwashers (1)Carts And Racks (1)Pictograms (1)Oxygencompatiblecleaners (1)FreeCPAPmaskfitting (1)CPAPTherapy (1)Oxygenvehicle (1)Non Flammablegasplacard (1)Oxygenplacard (1)Oxygenservice (1)Oxygenequipmentcleaner (1)Testimonals (1) + Show More
Free Subscription!

Get the latest regulatory info, accreditation news and exclusive discounts!

Applied University