TECHWIN
TECHWIN
Best Quality and Advanced Technology for our Customers
GMP建设
- assignment_turned_in 制药/食品成套设备（GMP施工）ENGINEERING/建设- 国内最大的生命科学GMP有经验公司
- assignment_turned_in 经济性的GMP工厂设计和建设服务。 - TECHWIN提供合理
- assignment_turned_in 完美的GMP设计、施工、VALIDATION、MAINTENANCE cGMP(FDA), EUGMP, KGMP, WHOGMP
- assignment_turned_in FDA、EUGMP工厂建设经验为基础，遵守GMP规定，执行适期VALIDATION,建造经济和合理的工厂，从而实现完美的生产体系。 (-设计/施工/Validation/Maintenance)
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GMPGood Manufacturing Practice
- 操作
- 工序
- 设施系统
- 原材料
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检查功能和状态，体系化地调查检讨及文件化 -
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有效性Efficacy
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安全性Safety
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安全性Stability
GMP 6 System
Quality System (QA)
- Packing & Labeling System
- Materials System
- Production System
- Laboratory Control System
- Facilities & Equipment System
Techwin 主要业务
- Civil & Architecture (Building Construction, Clean room)
- Mechanical (Process, Utility)
- Piping Syste (Process, Utility) - Seniary Piping, CIP, SIP
- HAVC System - Control System, AHU, DUCT, Clean 清洁设备
- Purfied System - PW, WFI, Clean Steam
- Instrument
- Electiric
- Process Control System
- Waste Water Treatment System (Kipp System, 生物化学处理)
- 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 (服务品种)
Service List
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Service 01
GMP PLANT新建及重修概念的设计
(Conceptual Design Study) 计算投资费 -
Service 02
GMP PLANT CONSTRUCTION
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Service 03
包括工序机械及设备的基本及详细设计
(Basic and Detail Design) -
Service 04
资格评估及批准 (DQ / IQ/ GQ/PQ)
编写VMP、CV、PV、CSV执行
GMP培训及文件管理SOPs -
Service 05
生产工序机械的购买及调配业务
(URS, FAT, SAT, Procurement) -
Service 06
MAINTENANCE(维修及维护)
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
- 1. Facility
- 2. Equipment
- 3. Process
- 4. Safety & Energy
- 5. Interaction(相互作用)
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- Preliminary GMP Level Review
- Hazop Study
- 编写DQ, IQ, OQ, PQ Protocol
Basic/Detail Design
Basic & Detail 编写Design Package
- 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
编写As Bult Package
- 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