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TECHWIN

첨단 환경기술을 바탕으로 최적 솔루션을 제공하기 위하여
현장조사, 분석, 설계, 제작, 사후관리에 이르기까지 고객의 요구사항을 만족시켜 드립니다.

GMP건설

주식회사 테크윈의 홈페이지를 방문해 주셔서 감사합니다.
  • assignment_turned_in 제약/식품 PLANT (GMP공사) Engineering / 건설 국내 최대 생명과학 GMP 유경험 회사
  • assignment_turned_in 합리적·경제적인 GMP 공장설계·건설 테크윈이 제공합니다.
  • assignment_turned_in 완벽한 GMP 설계, 시공, Validation, Maintenance cGMP(FDA), EUGMP, KGMP, WHOGMP
  • assignment_turned_in FDA, EUGMP 공장건설 경험을 기초로 GMP 규정준소, 적기 Validation 수행으로 완벽한 생산체제가 될 수 있도록 경제적이고 합리적인 공장을 건설합니다. (설계/시공/Validation/Maintenance)
  • GMPGood Manufacturing Practice

    • 조작
    • 공정
    • 시설시스템
    • 원재료

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    기능,상태 확인 체계적 조사 검토 및 문서화

    subdirectory_arrow_right subdirectory_arrow_right
  • subdirectory_arrow_right
    유효성Efficacy
  • 안전성Safety
  • subdirectory_arrow_left
    안정성Stability

GMP 6 System

Quality System (QA)

  • Packing & Labeling System
  • Materials System
  • Production System
  • Laboratory Control System
  • Facilities & Equipment System

Techwin 주요 업무

  • Civil & Architecture (Building Construction, Clean room)
  • Mechanical (Process, Utility)
  • Piping Syste (Process, Utility) - Seniary Piping, CIP, SIP
  • HAVC System - Control System, AHU, DUCT, Clean 기기
  • Purfied System - PW, WFI, Clean Steam
  • Instrument
  • Electiric
  • Process Control System
  • Waste Water Treatment System (Kipp System, 생물학적 처리)

  • VMP (Validation Master Plan)
  • IQ (Installation Qualification)
  • OQ(Operation Qualification)
  • PQ(Performance Qualification)
  • Maintenance System
  • Calibration System
  • Utility Operation
  • SOPs(Standard Operation Procedures)

Service List (서비스 품목)

Service List

  • Service 01

    GMP PLANT 신축 및 리모델링 개념 설계
    (Conceptual Design Study) 투자비 산출

  • Service 02

    GMP PLANT CONSTRUCTION

  • Service 03

    공정기계 및 설비를 포함한 기본 및 상세 설계
    (Basic and Detail Design)

  • Service 04

    적격성 평가 및 밸리데이션 (DQ / IQ/ GQ/PQ)
    VMP작성, CV, PV, CSV 수행
    GMP 교육 및 문서관리 SOPs

  • Service 05

    생산공정기계의 구매 및 조달업무
    (URS, FAT, SAT, Procurement)

  • Service 06

    MAINTENANCE(하자처리 및 유지보수)

Service Prcedure

  • STEP 1

    DESIGN

    Concept Design
    Basic Design
    Detail Design

  • STEP 2

    CPMSTRICTOPN

    Bulding / Construction
    HWAC /Clean Room Ststem
    Water System
    Piping System (Process, Utility) Electric, Instrument, Auto-Control
    Waste Water System

  • STEP 3

    VALIDATION

    VMP (Validation Master Plan)
    IQ (Installation Qualification)
    OQ(Operation Qualification)
    PQ(Performance Qualification)
    CV(Cleaning Validation
    SMF(Site Master File)

  • STEP 4

    MAINTENANCE

    PM (Preventive Maintenance)
    Hepa Filter Management
    Calibration
    Drawing Management
    Utility Operation

Techwin Strong Point

TECHWIN Strong Point

  • Conceptual / Basic / Detail Design Ability
    • CIP System Ability
    • Center Control System Ability
  • Construction Ability
    • Sip System Ability
    • Water System Ability
  • Validation Ability
    • HAVC System Ability
    • Process Piping Ability

GMP Plant Process - including validationt

Validation Point
    • GMP Level1 & Safety Review
    Conceptual Design Study
    Concept Study Package 작성
    • 1. Facility
    • 2. Equipment
    • 3. Process
    • 4. Safety & Energy
    • 5. Interaction(상호작용)
    • Preliminary GMP Level Review
    • Hazop Study
    • DQ, IQ, OQ, PQ Protocal 작성
    Basic/Detail Design
    Basic & Detail DesignPackage 작성
    • 1. Facility
    • 2. Equipment
    • 3. Process
    • 4. Civil & Architectural
    • 5. Mechanical (Piping)
    • 6. HAVC System
    • 7. Water System
    • 8. Instrument & Electric
    • 9. Control System
    • IQ Protocol Approval
    • OQ Protocol Approval
    • PQ Protocol Approval
    Construction
    Construction Execution
    • 1. Facility
    • 2. Equipment
    • 3. Process
    • 4. Civil & Architectural
    • 5. Mechanical (Piping)
    • 6. HAVC System
    • 7. Water System
    • 8. Instrument & Electric
    • 9. Control System
    • IQ Execution Approval
    • OQ Execution Approval
    • PQ Execution Approval
    IQ, OQ, PQ
    AS Built Package 작성
    • IQ Execution & Result Report
    • OQ Execution & Result Report
    • PQ Execution & Result Report
    • Process Validation Approval
    • Stability Test Approval
    • Cleaning Validation Approval
    Pre Production
    • Process Validation Protocol & Result Report
    • Stability Test Protocol & Result Report
    • Cleaning Validation Protocol & Result Report
Action Point
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