TECHWIN
TECHWIN
Best Quality and Advanced Technology for our Customers
GMP Construction
- assignment_turned_in Pharmaceutical/food plan (GMP construction) Engineering/construction he most experienced company in domestic life science GMP
- assignment_turned_in Reasonable & economic GMP plant design and construction provided by Techwin
- assignment_turned_in Perfect GMP design & construction, validation, maintenance cGMP(FDA), EUGMP, KGMP, WHOGMP
- assignment_turned_in We build economic and reasonable plant to accomplish perfect production system by complying with GMP regulation and carrying out timely validation based on experiences on FDA and EUGMP plant construction(Design/Construction/Validation/Maintenance)
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GMPGood Manufacturing Practice
- Manipulation
- Process
- Facility system
- Raw material
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Verification of function and condition, systemic inspection review & documentation -
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Efficacy
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Safety
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Stability
GMP 6 System
Quality System (QA)
- Packing & Labeling System
- Materials System
- Production System
- Laboratory Control System
- Facilities & Equipment System
Major tasks of Techwin
- Civil & Architecture (Building Construction, Clean room)
- Mechanical (Process, Utility)
- Piping Syste (Process, Utility) - Seniary Piping, CIP, SIP
- HAVC System - Control System, AHU, DUCT, Clean device
- Purfied System - PW, WFI, Clean Steam
- Instrument
- Electiric
- Process Control System
- Waste Water Treatment System (Kipp System, biological processing)
- 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(service item)
Service List
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Service 01
GMP plant design with new construction and remodeling concept Investment cost computed
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Service 02
GMP PLANT CONSTRUCTION
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Service 03
Basic & detailed design including process machineries and facilities
(Basic and Detail Design) -
Service 04
Assessment of eligibility and validation (DQ/IQ/OQ/PQ)
VMP prepared, CV, PV, CSV performed
GMP education and document management SOPs -
Service 05
Purchase and procurement duties for production process machineries
(URS, FAT, SAT, Procurement) -
Service 06
Defect treatment and maintenance
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
Preparation of Concept Study Package
- 1. Facility
- 2. Equipment
- 3. Process
- 4. Safety & Energy
- 5. Interaction
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- Preliminary GMP Level Review
- Hazop Study
- Preparation of DQ, IQ, OQ, PQ Protocal
Basic/Detail Design
Preparation of Basic & Detail DesignPackage
- 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
Preparation of As Built 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