Corporate Profile IVS 03 3 GMP Design Reviews
- Slides: 24
Corporate Profile ㈜IVS 03. 3 주식회사 전환 진명테크 • • GMP Design Reviews Commissioning Quality Assurance Validation Management Calibration Programs Environmental Monitoring Program Internal Audit Training Programs 97. 5 • 자본금 : 2억 • 구성원 : 9명 ADD. : TEL : FAX : WEB : 경기도 수원시 팔달구 원천동 92 -8 대신전자빌딩 2층( 우 443 -380 ) (031) 217 -5540, (0502) 735 -5255 (031) 217 -5541 www. validation. co. kr
Service Area of IVS 1 GMP design reviews • Facility : Layout, HVAC zoning, …… • Utility • Establishment of design specification for facility , utility and equipment • Process water : Purified water and WFI production and distribution system • Material flow • Personnel flow • Process flow • Waste flow including biological waste kill system
Service Area of IVS 2 Commissioning Quality Assurance • Commissioning test of HVAC in environmentally controlled areas • Passivation and sanitation of WFI distribution system • Participation in internal audit • Process analysis to determine the state of a process and recommend the corrective actions needed to control variation • Establishment of Documentation system
Service Area of IVS 3 Validation management • • • Validation master plan establishment Qualification of some equipment Cleaning validation Aseptic process validation and personnel qualification Media fill Sterilization validation Purification process validation Chromatographic separation process validation WFI and process water system validation Automated system validation
Service Area of IVS 5 Preparation of Environmental Monitoring Program • Determination of clean room classification • Evaluation of criteria based on ISO 14644, FDA guide, EU guide, WHO guide. • Determination of alert and action limit by each clean room and/or classification • Management of corrective action programs and problem solving
Service Area of IVS 6 Participation in Internal Audit • Executed by qualified specialists • Well established audition programs • Investigation into deviations • GMP improvement by problem solving
보유계측기 No Instrument 1 Intelligent RTD Probe & Validator 16 DP calibrator (Dwyer) 2 Ice Point Reference 17 Frequency counter 3 High Temperature Reference 18 Electronic level 4 Oil bath 19 Data logger & Humidity transmitter 5 Calibrator 20 Lightmeter 6 Microbiological Air sampler 21 Radiometer 7 Airborne Particle counter 22 Decade resistance box 8 Aerosol photometer DOP aerosol generator 23 Stopwatch timer 9 Low Pressure calibrator 24 Insulation tester 10 High Pressure calibrator 25 Sound meter 11 Air volume meter Air velocity probe 26 Multimeter 12 Air velocity meter (Velometer-6000 APM) 27 Clamp meter (Kyoritsu) 13 Tri-sense meter 28 Clamp meter (Hioki) 14 RTD Handheld Thermometer 29 Temperature/Humidity meter 15 DP calibrator (Meriam Instr. ) 30 Tachometer