Qualifications

2007 – 2011

  • Hemofarm JSC, Vršac – (Plant for injection products, Department of lyophilized products (including laboratories and warehouses) – Inspection by the Food and Drug Administration (FDA), USA – IQ/OQ HVAC, clean rooms and BMS systems, writing and execution of the protocol, report writing; IQ/OQ/PQ system for production and distribution of PW, WFI, PS, writing and execution of the protocol, report writing; IQ/OQ system for distribution of compressed air, writing and execution of the protocol, report writing; IQ/OQ system for distribution of nitrogen, writing and execution of the protocol, report writing; IQ/OQ of production equipment (system for solution preparation, line for washing, sterilization, depyrogenisation and filling of bottles, Crimping machine, lyophilisator, laminar flow cabinets, autoclave …), writing and execution of the protocol, report writing

2010

  • Hemofarm JSC, Vršac – (Department of infusions, Plant for sterile products) – Inspection by SachsenAnhaltLandesverwaltungsamt, Germany – IQ/OQ HVAC, clean rooms and BMS systems, writing and execution of the protocol, report writing; IQ/OQ/PQ system for production and distribution of PW, WFI, PS, writing and execution of the protocol, report writing
  • Hemofarm JSC, Vršac – (Department of ampoules, Plant for injection products (including laboratories and warehouses) – Inspection by Regierungspräsidium Darmstadt, Germany – IQ/OQ HVAC, clean rooms and BMS systems, writing and execution of the protocol, report writing; IQ/OQ/PQ system for production and distribution of PW, WFI, PS, writing and execution of the protocol, report writing; IQ/OQ system for distribution of compressed air, writing and execution of the protocol, report writing; IQ/OQ system for distribution of nitrogen, writing and execution of the protocol, report writing; IQ/OQ of production equipment (system for solution preparation, line for washing, sterilization, depyrogenisation and filling of bottles, Crimping machine, lyophilisator, laminar flow cabinets, autoclave …), writing and execution of the protocol, report writing
  • Hemofarm JSC, Vršac – (Plant for sterile products, Department of lyophilized products) – Inspection by the National Agency for Medicines – ANM, Romania – IQ/OQ HVAC, clean rooms and BMS systems, writing and execution of the protocol, report writing; IQ/OQ/PQ system for production and distribution of PW, WFI, PS, writing and execution of the protocol, report writing; IQ/OQ system for distribution of compressed air, writing and execution of the protocol, report writing; IQ/OQ system for distribution of nitrogen, writing and execution of the protocol, report writing; IQ/OQ of production equipment (system for solution preparation, line for washing, sterilization, depyrogenisation and filling of bottles, Crimping machine, lyophilisator, laminar flow cabinets, autoclave …), writing and execution of the protocol, report writing

2010 – 2012

  • Hemofarm Ltd, Belgrade – (Plant for solid dosage forms) – Inspection by Regierungspräsidium Darmstadt, Germany – IQ/OQ HVAC, clean rooms, writing and execution of the protocol, report writing; IQ/OQ/PQ system for production and distribution of PW, writing and execution of the protocol, report writing; IQ/OQ of production equipment (tabletting equipment, packaging lines), writing and execution of the protocol, report writing
  • Hemofarm JSC, Vršac – (Plant for solid dosage forms (including laboratories and warehouses)) – Inspection by Regierungspräsidium Darmstadt, Germany – IQ/OQ HVAC, clean rooms and BMS systems, writing and execution of the protocol, report writing; IQ/OQ/PQ system for production and distribution of PW, writing and execution of the protocol, report writing; IQ/OQ system for distribution of compressed air, writing and execution of the protocol, report writing; IQ/OQ of production equipment (equipment for coating tablets, packaging lines, device for foil printing…), writing and execution of the protocol, report writing

2011

  • Hemofarm JSC, Vršac – (Plant for sterile products, Department of lyophilized products) – Inspection by StaatlichesGewerbeaufsichtsamtHannover, Germany – IQ/OQ HVAC, clean rooms and BMS systems, writing and execution of the protocol, report writing; IQ/OQ/PQ system for production and distribution of PW, WFI, PS, writing and execution of the protocol, report writing; IQ/OQ system for distribution of compressed air, writing and execution of the protocol, report writing; IQ/OQ system for distribution of nitrogen, writing and execution of the protocol, report writing; IQ/OQ of production equipment (system for solution preparation, line for washing, sterilization, depyrogenisation and filling of bottles, Crimping machine, lyophilisator, laminar flow cabinets, autoclave …), writing and execution of the protocol, report writing

2011 – 2013

  • Hemofarm JSC, Vršac – (Plant for injection products, Department of ampoules (including laboratories and warehouses)) – Inspection by Therapeutic Goods Administration (TGA), Australia – IQ/OQ HVAC, clean rooms and BMS systems, writing and execution of the protocol, report writing; IQ/OQ/PQ system for production and distribution of PW, WFI, PS, writing and execution of the protocol, report writing; IQ/OQ system for distribution of compressed air, writing and execution of the protocol, report writing; IQ/OQ system for distribution of nitrogen, writing and execution of the protocol, report writing; IQ/OQ of production equipment (system for solution preparation, line for washing, sterilization, depyrogenisation and filling of ampoules, laminar flow cabinets, autoclave, packaging line), writing and execution of the protocol, report writing

2013

  • Hemofarm JSC, Vršac – (Plant for injection products, Department of lyophilized products (including laboratories and warehouses)) – Inspection by Therapeutic Goods Administration (TGA), Australia – IQ/OQ HVAC, clean rooms and BMS systems, writing and execution of the protocol, report writing; IQ/OQ/PQ system for production and distribution of PW, WFI, PS, writing and execution of the protocol, report writing; IQ/OQ system for distribution of compressed air, writing and execution of the protocol, report writing; IQ/OQ system for distribution of nitrogen, writing and execution of the protocol, report writing; IQ/OQ of production equipment (system for solution preparation, line for washing, sterilization, depyrogenisation and filling of bottles, Crimping machine, lyophilisator, laminar flow cabinets, autoclave …), writing and execution of the protocol, report writing
  • Hemofarm JSC, Vršac – (Plant for sterile products, Department of lyophilized products) – Inspection by Therapeutic Goods Administration (TGA), Australia – IQ/OQ HVAC, clean rooms and BMS systems, writing and execution of the protocol, report writing; IQ/OQ/PQ system for production and distribution of PW, WFI, PS, writing and execution of the protocol, report writing; IQ/OQ system for distribution of compressed air, writing and execution of the protocol, report writing; IQ/OQ system for distribution of nitrogen, writing and execution of the protocol, report writing; IQ/OQ of production equipment (system for solution preparation, line for washing, sterilization, depyrogenisation and filling of bottles, Crimping machine, lyophilisator, laminar flow cabinets, autoclave …), writing and execution of the protocol, report writing