테크윈
테크윈
첨단 환경기술을 바탕으로 최적 솔루션을 제공하기 위하여
현장조사, 분석, 설계, 제작, 사후관리에 이르기까지 고객의 요구사항을 만족시켜 드립니다.
GMP건설
- 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)
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GMPGood Manufacturing Practice
- 조작
- 공정
- 시설시스템
- 원재료
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기능,상태 확인 체계적 조사 검토 및 문서화 -
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유효성Efficacy
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안전성Safety
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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
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Service 01
GMP PLANT 신축 및 리모델링 개념 설계
(Conceptual Design Study) 투자비 산출 -
Service 02
GMP PLANT CONSTRUCTION
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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
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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
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Conceptual / Basic / Detail Design Ability
- CIP System Ability
- Center Control System Ability
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Construction Ability
- Sip System Ability
- Water System Ability
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Validation Ability
- HAVC System Ability
- Process Piping Ability
GMP Plant Process - including validationt
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- GMP Level1 & Safety Review
Conceptual Design Study
Concept Study Package 작성
- 1. Facility
- 2. Equipment
- 3. Process
- 4. Safety & Energy
- 5. Interaction(상호작용)
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- 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
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- 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
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- 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
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- 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