Loading presentation...

Present Remotely

Send the link below via email or IM

Copy

Present to your audience

Start remote presentation

  • Invited audience members will follow you as you navigate and present
  • People invited to a presentation do not need a Prezi account
  • This link expires 10 minutes after you close the presentation
  • A maximum of 30 users can follow your presentation
  • Learn more about this feature in our knowledge base article

Do you really want to delete this prezi?

Neither you, nor the coeditors you shared it with will be able to recover it again.

DeleteCancel

Make your likes visible on Facebook?

Connect your Facebook account to Prezi and let your likes appear on your timeline.
You can change this under Settings & Account at any time.

No, thanks

현대-프리젠테이션

intro
by

oh samil

on 14 April 2016

Comments (0)

Please log in to add your comment.

Report abuse

Transcript of 현대-프리젠테이션

PROJECT LIFE CYCLE
Process
OQ
VR
IQ
GxP
개발
Development
설계
Design
업무분석
Project Analysis
준비
Preparations
PQ
FS
DS
기능사양
설계사양
URS
요구사항
DQ
설계 적격성
VP
벨리데이션 계획
Test
(결합 Test/
시스템 테스팅
이행
(운용 Test/
실전 이행)
적격성
적격성
설치 적격성평가
운전 적격성평가
성능 적격성평가
벨리데이션 보고
적격성
Process
Qualification
Implementation
시스템 구축
IQ, Installation
Qualification
OQ, Operational
Qualification
PQ, Performance
Qualification
User Requirement
사용자 요구
Functional Design
대략적 설계
Detail Design
제작 설계
IQ Test Plan
OQ Test Plan
PQ Test Plan
Impact Assessment
Change Control
Design
Development
Enhanced Design
Review
● S-TECH는 장기적인 안목으로 설계부터 Validation까지 포괄할 수 있는 경험과 지원서비스로 시장의 요구에 부응하고 한국제약 및 화장품 산업이 세계적인 수준으로 성장할 수 있도록 노력하겠습니다.
Fact Sheet
회 사 명 : 에스테크
사업분야 : GMP 관련 종합 서비스
주 소 : 경기도 안산시 단원구 고잔동 705-4
동일프라자 403호
전 화 : 031) 475 - 5311
Fax : 031) 439 - 5311
Web-site : www.ispe.co.kr
문 의 : 31@ispe.co.kr
CI Information
제약 및 화장품산업은 다수의 보건 당국(KFDA, US FDA, WHO-GMP, EU-GMP 등)으로부터 매우 엄격하고 다양한 규제를 받고 있습니다.
에스테크는 장기적인 안목을 가지고 활동합니다.

Concept Design은 물론 EQ부터 CSV 까지

2013년의 KFDA의 계획에 따라 진행할 수 있는

시스템을 갖추고 있습니다.
General Information
Project Organization
Business Scope
Project Process
S-TECH History
Validation
Qualification
Calibration
Inspection(PDI)
PROJECT CLOSE OUT & TURN OVER
FAT
SAT
COMMISSIONING
ENGINEERING CHANGE MANAGEMENT
SUB-VENDOR MANAGEMENT
COST CONTROL
SCHEDULE DEVELOPMENT & CONTROL
DOCUMENT PLANNING & CONTROL
GMP Compliance
GET Supporting
QUALITY MANAGEMENT
GMP
PROJECT
GEP PROJECT의 대전제
1996
Sebong Computer (Samsung Subsidiary Korea)
Project : Network Design and Setup
2000
Simize. CO.LTD (Tokyo Japan))
Project : Managed the automated entry/exit system.
Managed the building automation.
2001
2004
2005
APVS CO.LTD
Project : Manufacturing Systems – CSV, GMP Consultant
Received training in GMP and Computer System
Validation.
2006
Sae Hyun Tech
Project : Prepared validation protocols for Data Logger
software Systems
2007
한미정밀화학 Hanmi
(Rank-No 5)

Project: Computer System Validation services for equipments
Project Management for HVAC Validation
유영제약
(Rank-No 50)
Project: Computer System Validation for WMS
KITECH (생물산업기술 실용화 센터, 송도)
Project: Temperature Monitoring System
한림제약 Hanlim
(Rank-No 36)

Project: Retrospective Equipment Qualification(6)
하나제약 Hana
(Rank-No in 50)

Project: Computer System Validation for HVAC Validation
동아제약 Dong-a
(Rank-No1)

Project: 용매조제조 Equipment Qualification
PMP, QP, DS, FS, IQ, OQ
신풍제약 Shinpoong
(Rank-No14)

Project: SS 결정조 Equipment Qualification
부광약품 Bukwang
(Rank-No in top 50)

Project: Hot Wind Dry System Validation (PLC)
K-TECH
Project: Reactor, Autoclave Equipment Validation
(Touch Screen & PLC & PC S/W)
동방 FTL
(Rank-No in top 50)

Project: PW System Equipment Qualification
보령제약 Boryung
(Rank-No 12)
Project: Reactor, Vacuum Dryer외 32개 Equipment Validation
(Touch Screen & PLC & PC S/W)
CJ제약 CJ
(Rank-No in top 50)

Project: LIMS Equipment validation protocols for Data Logger (CSV)
세현테크
Project: Equipment validation protocols for WinLog Pharm (CSV)
두구코리아
Project: Reactor, Vacuum Dryer Equipment Validation
(Touch Screen & PLC & PC S/W)
보령바이오파마 Boryung
(Rank-No 12)

Project: Reactor, Autoclave Equipment Validation (Touch Screen & PLC & PC S/W)
신풍제약 Shinpoong
(Rank-No 14)

Project: Reactor Equipment Qualification
(Touch Screen & PLC)
보령제약 Boryung
(Rank-No 12)

Project: 합성동 Equipment Validation
(Touch Screen & PLC & PC S/W) (CSV)
건양대학교 Kunyang University
Project: 실험설비 Equipment Validation
(Touch Screen & PLC & PC S/W) (CSV)
녹십자 수원 Green Cross
(Rank-No 2)

Project: 광입자분석 실험설비 Equipment Validation (Touch Screen & PLC & PC S/W) (CSV)
녹십자 오창 Green Cross
(Rank-No 2)

Project: 실험설비 Equipment Validation
(Touch Screen & PLC) (CSV)
한림제약 Hanlim
(Rank-No 36)
Project: 칭량 System Validation(CSV)
동아제약 Dong-a
(Rank-No 1)

Project: 용매회수탑 Retrospective Equipment Qualification
동방에프티엘 Dongbang
(Rank-No in top 50)

Project: Reactor Equipment Validation
(IQ,OQ,PQ)
종근당바이오 Jonggundang
(Rank-No 25)

Project: Air Jet Mill Equipment Validation
보령제약 Boryung
(Rank-No 12)

Project: 유동층 과립건조기 외 3대 Equipment Validation
(Touch Screen & PLC & PC S/W) (CSV)
보령제약 Boryung
(Rank-No 12)

Project: Autoclave, Nano Mill Equipment Validation
(Touch Screen & PLC) (CSV)
신풍제약 Shinpoong
(Rank-No 14)

Project: LVP 수액조제 Tank, 사면 Filling Machine Equipment Validation
(Touch Screen & PLC )
동아제약 Dong-a
(Rank-No 1)
Project: Reactor, Vacuum Dryer 등 Total 7대 Equipment Validation
(Touch Screen & PLC & PC S/W)
CJ 제일제당 CJ
(Rank-No in top 50)

Project: Air Jet Mill Equipment Validation
2012
Chungho Com Net CO.LTD
Project : Technical sales of office automation systems.
Primary vendor for Kia Motors Participated in a
project to redesign and move an atmospheric
testing laboratory.
감사합니다.
Thank you

S
-T
E
C
H

Department of

GxP Service
Department of
Qualification
HVAC
CleanRoom
Water
Equipment
LAB
Validation
Training
Regulation
IT Design
Software
PLC
Department of
CSV
Support Team
Audit
Facility layout drawing, basic architecture drawing
Flow management (materials, equipment, personnel)
Utility requirements
Equipment recommendations
Automation recommendations
Basic/Final Design
Application Software / PLC based automation Equipment
IT Design
Calibration Management Software
Database Systems
Enterprise Resource Planning Software (ERP)
Laboratory Information Management System (LIMS)
Electronic Document Management System (EDMS)
Training Management Software
Change Management Software
Product Tracking Software
Supervisory Control and Data Acquisition (SCADA)
Distributed Control System (DCS)
Building Management System (BMS)
Process Control System workstation
Product Flow Controller
Mixing Tank Controller
Storage Tank Controller
PLC-based equipment
HVAC Management System
Cleanroom Controller
Monitoring Management System
Training Program Development
Validation Protocols and Report
Facility layout drawing, basic architecture drawing
Flow management (materials, equipment, personnel)
Utility requirements
Equipment recommendations
Automation recommendations
Quality Plan / Process Control etc.
Document Management
Change Control
Training.
Configuration Management.
Records Retention.
Procedure Development.
Investigation
Validation Revalidation.
DQ,IQ,OQ,PQ
User Requirement Specification
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
Temperature Mapping
HVAC System / PW Water System etc.
Facility Validation
Utility Validation
HVAC Qualification
Room Pressure Differential
Clean Room Qualification
Purified Water (PW) and Water-For-Injection (WIFI) Validation
Production Gas Validation
Piping Qualification
Warehouse Qualification
Infrared Thermometer
Digital Tachometer
Digital Leveler
Data Logger
Thermometer
Data Logger
Thermometer
Pressure gauge
Data Logger
Thermometer
Hygrometer
Stop Watch
Digital Hitester
Clamp On Hitester
Digital Lux Meter
Sound Level Meter
Dae Shin Information System (Korea)
Project : Part of a team that developed an ERP system.
Digital Hitester
Digital Manometer
Thermometer
Particle Counter
Calibrator
END
설계적격성평가
디자인 규격서
P&ID
DRAWINGS
ENGINEERING DOCUMENTS
시스템(장비 및 설비)의 제작 및 FAT단계
Incoming
Fabrication
FAT
외관검사
수량검사
규격검사
Engineering Quality Control
(제작 단계별 품질시험 및 문서관리)
Static Test
Dynamic Test
(Performance Testing)
Inspection
PDI
Delivery
Design & Construction
Turn Over Package
설치단계
CONSTRUCTION DOCUMENTS
SAT
Installation
Commissioning
Mechanical Installation
Utility Construction
P&ID Checks
Vendor Installation Check
Loop Check
Line Flushing etc
SAT-Installation
P&ID Checks
Panel / Unit Wiring
Installation Verification
Mechanical
Completion
*사용자 측면의 품질보증활동
COMMISSIONING
Operational
Commissioning
SAT-Operation
Test Runs
Control System functionality
Installation Verification
Commissioning
Extended Test Runs
Interface Systems
Max./Min. Loads
Cycle Development
Performance Testing
Pre-OQ
COMMISSIONING DOCUMENTS
공급자 측면의 품질보증 활동
IQ
OQ
PQ
Qualification
Validation
Turn Over
Commissioning
Qualification Turn Over
Package
End User
EU-GMP 및 cGMP에 대한 요구사항에 부합하는 GMP 공장 신축
및 Renovation과 관련된 설계 검토 및 전반적인 Consulting.

제조 지원 설비, 생산 설비 및 제조 공정에 대한 Qualification 및
Validation Services (VMP, URS, DQ, IQ, OQ, PQ, PV, CV 등)

Quality Management System Building. Consulting & Services
(SOP, Maintenance Program, Calibration Program etc.)

Training program building related to the GMP Service
Temperature Monitoring Validation Equipment Sales


Design Protocol
DS
Digital Airflow Meter
2008 S-TECH Establishment
동아제약 Dong-a
(Rank-No 1)

Project: 용매회수탑 Retrospective Equipment Qualification
동방에프티엘 Dongbang
(Rank-No in top 50)

Project: Reactor Equipment Validation
(IQ,OQ,PQ)
종근당바이오 Jonggundang
(Rank-No 25)

Project: Air Jet Mill Equipment Validation
보령제약 Boryung
(Rank-No 12)
Project: 유동층 과립건조기 외 3대 Equipment Validation
(Touch Screen & PLC & PC S/W) (CSV)
보령제약 Boryung
(Rank-No 12)

Project: Autoclave, Nano Mill Equipment Validation
(Touch Screen & PLC) (CSV)
신풍제약 Shinpoong
(Rank-No 14)

Project: LVP 수액조제 Tank, 사면 Filling Machine Equipment Validation
(Touch Screen & PLC )
동아제약 Dong-a
(Rank-No 1)
Project: Reactor, Vacuum Dryer 9대 Equipment Validation
(Touch Screen & PLC & PC S/W)
CJ 제일제당 CJ
(Rank-No in top 50)
Project: Air Jet Mill Equipment Validation
녹십자 Green Cross
(Rank-No 2)

Project: Data Transfer System (PC S/W) (CSV)
동아제약 Dong-a
(Rank-No 1)

Project: Pasteurizer, Pocket Rinser Equipment Validation
(Touch Screen & PLC )
동아제약 Dong-a

(Rank-No 1)

Project: Disk Stoppering Inspector Equipment Validation (Touch Screen & PLC & PC S/W) (CSV)
IT System
Equipment
Test equipment
Sae Hyun Tech
Project : Prepared validation protocols for Data Logger software Systems validation
글로벌 제약 Global
(Rank-No in top 50)
Project : HVAC System and Equipment Validation
23-EA
보령제약 Boryung

(Rank-No 12)

Project: HVAC System and Equipment Validation
7-EA
보령제약 Boryung

(Rank-No 12)

Project: SMS Monitoring System Validation
동아제약 Dong-a
(Rank-No 1)

Project: DRY Oven Equipment Validation (Touch Screen & PLC & PC S/W) (CSV) 7-EA
신풍제약 Shinpoong

(Rank-No 14)

Project: Tank & Reactor Equipment Validation
(Touch Screen & PLC ) 3-EA
명인제약 Myungin

(Rank-No 42)

Project: Air Jet Mill Equipment Validation
엔에스팜 NS
(Rank-No in top 50)
Project: GC Equipment Validation
종근당바이오 Jonggundang
(Rank-No 25)

Project: Filter Press Equipment Validation
오츠카 Otsuka
(Rank-No 39)

Project: Reactor Equipment Validation
동아제약 Dong-a
(Rank-No 1)

Project: Reactor Equipment Validation
(Touch Screen & PLC ) 2-EA
동아제약 Dong-a
(Rank-No 1)

Project: HVAC Validation
(Touch Screen & PLC )
신풍제약 Shinpoong
(Rank-No 14)

Project: Injection Filling machine Equipment Validation (Touch Screen & PLC )
보령제약 Boryung
(Rank-No 12)

Project: Labeler Equipment Validation
(Touch Screen & PLC) (CSV) 2-EA
녹십자 Green Cross
(Rank-No 2)

Project: Cold storage System (PC S/W) (CSV)
동아제약 Dong-a
(Rank-No 1)

Project: Vision Inspection Equipment Validation
(Touch Screen & PLC ) 2-EA
2013
HVAC
보령제약 Boryung
(Rank-No 12)

Project : Rotary Vacuum Dryer Equipment Validation & Change Control Validation
보령제약 Boryung
(Rank-No 12)

Project: X-ray Inspection System Validation
보령제약 Boryung
(Rank-No 12)

Project: Kanarb Line Building& oral solid dosage System Vaildaion
보령제약 Boryung
(Rank-No 12)

Project: Gelfos 4th Equipment Validation
보령제약 Boryung
(Rank-No 12)

Project: Gelfos 5th Equipment Validation
보령제약 Boryung
(Rank-No 12)

Project: Storage Tank Equipment Vaildaion of Crude Drug line
보령제약 Boryung
(Rank-No 12)

Project: Bottle washing machine Validation of Crude Drug line
보령제약 Boryung
(Rank-No 12)

Project: Moment Sterilizer Equipment Validation of Crude Drug line
보령제약 Boryung
(Rank-No 12)

Project: Posgel charger Equipment Validation
& GMP Document
보령제약 Boryung
(Rank-No 12)

Project: Preperation Tank Equipment Validation
보령제약 Boryung
(Rank-No 12)

Project: Temperature Monitoring System Validation
보령제약 Boryung
(Rank-No 12)

Project: Kanarb Line Building HVAC-CSV
신풍제약 Shinpoong
(Rank-No 14)

Project: Reactor 3000L Equipment Validation
동아제약 Dong-a
(Rank-No 1)

Project: Hot well Dryer Equipment Validation
바이오랜드 Bio Land
Project: Filter Press Equipment Validation
대웅제약(향남) Daewoong(Hyangnam)
(Rank-No 4)
Project: Production Equipment Validation
대웅제약(향남) Daewoong(Hyangnam)
(Rank-No 4)
Project: Swipe Machine Validation
대웅제약(성남) Daewoong(Sungnam)
(Rank-No 4)
Project: Production Equipment Validation
종근당바이오 (CKD BIO)
(Rank-No 25)

Project: Fluid Bed Dryer Equipment Validation
동방FTL Dongbang FTL
(Rank-No in top 50)

Project: Suction Filter Equipment Validation
셀루메드 Cellumed
Project: Maching Center Equipment Vailidation 20-EA
대웅제약(성남) Daewoong(Sungnam)
(Rank-No 4)

Project: PTP Leak Tester Equipment Validation
대웅제약(향남) Daewoong(Hyangnam)
(Rank-No 4)

Project: PTP Leak tester Equipment Validation
진양제약 Jinyang
Project: Bottle Labeler Equipment Validation
신풍제약 Shinpoong
(Rank-No 14)

Project: Change Control Validation
건일제약 Kuhnil
Project: Stick Packing Machine Validation
SK 케미칼 SK Chemicals
Project: Slitting Machine Validation
셀트리온 Celltrion

Project: Labeler Equipment Validaion
종근당 바이오 CKD BIO
(Rank-No 25)

Project: Purified System Validation
한림제약 Hanlim
(Rank-No 36)

Project: Equipment Validation 36-EA
동아제약 (합성2동) Dong-a (Synthesis API Building2)
(Rank-No 1)

Project: HVAC System Validation
동아제약 Dong-a
(Rank-No 1)

Project: Low temperature Storage Room of Raw Material Validation
한림제약 Hanlim
(Rank-No 36)

Project: Dryer Equipment Validation 5-EA
동방FTL DongbangFTL
(Rank-No in top 50)
Project: Clean Benches Equipment Validation
동방FTL DongbangFTL
(Rank-No in top 50)
Project: thermo-hygrostat Equipment Validation
신풍제약 Shinpoong
(Rank-No 14)

Project: Change Control Vailidation
대웅제약(향남) Daewoong(Hyangnam)
(Rank-No 4)
Project: Hardness Equipment Validation
동아제약 Dong-a
(Rank-No 1)

Project: Buchi Reactor Equipment Validation
세현테크 Saehyun
Project: Ebro Software Vailidation
동아제약 Dong-a
(Rank-No1)

Project: Retrospective Equipment Qualification
부광약품 Bukwang
(Rank-No in 50)

Project: Prospective Equipment Qualification
신풍제약 Shinpoong
(Rank-No14)

Project: Prospective Equipment Qualification for 34EA Equipments Validation for PW & WFI System
동인당제약 Dongindang
(Rank-No in top 50)

Project: High Pressure Homogenizer System Validation (Touch Screen & PLC)
알파테크
Project: High Pressure Homogenizer System Validation
(Touch Screen & PLC)
동아제약 Dong-a
(Rank-No 1)
Project: PW System Validation (Touch Screen & PLC)
동아제약 Dong-a
(Rank-No 1)

Project: Cold Storage Room System Validation (PLC)
신풍제약 Shinpoong
(Rank-No 14)

Project: Filter Dryer Equipment Qualification
(Touch Screen & PLC)
종근당바이오 Jonggundang
(Rank-No 25)

Project: Jet Mill Equipment System Validation
(Touch Screen & PLC)
동구제약 Dongu
(Rank-No in top 50)

Project: Homo Mixer Equipment Qualification
(PLC)
삼진제약 Samjin
(Rank-No 15)

Project: Reactor, Vacuum Dryer Equipment Validation (Touch Screen & PLC & PC S/W)
한림제약 Hanlim
(Rank-No 36)

Project: PW System Validation, PS System Validation, WFI System Validation
(Touch Screen & PLC)
한국산업보건공단
Korea Industrial Health Agency
Project: 실험장비 4대 Equipment Validation(CSV)
일동제약 Ildong
(Rank-No 10)

Project: Blister Packaging Machine Equipment Validation (CSV)
에스텍파마 Estech
Project: Reactor 외 Total 25대 Equipment Validation(CSV)
HVAC, PW System Validation (CSV)
자생한방병원
Jaseng Oriental Hospital
Project: Validation Autoclave 외 장비 5대 Equipment Validation(Touch Screen & PLC & PC S/W) (CSV)
SK 케미컬 SK
(Rank-No in top 50)

Project: Multi Coater Machine System Equipment Validation
신성 테크
Project: Reactor, Vacuum Dryer Equipment Validation
(Touch Screen & PLC & PC S/W)
케이피에릭슨
(Rank-No in top 50)

Project: Ultra PW System Equipment Validation
보령제약
(Rank-No 12)

Project: Reactor Equipment Validation
2008
신풍제약 Shinpoong
(Rank-No 14)
Project: Labeler Equipment Validaion
동방FTL DongbangFTL
(Rank-No in top 50)
Project: Centrifugal Separator & HVAC System
& Purified Equipment Validation
서울제약 Seoul
Project: Compressed System Validation
대웅제약(향남) Daewoong(Hyangnam)
(Rank-No 4)
Project: Manual Inspector Validation
동아제약(달성) Dong-a(Dalsung)
(Rank-No 1)

Project: Labeler Equipment Validation
동아제약(천안) Dong-a(Cheon-An)
(Rank-No 1)

Project: Sub Tank Washing Machine Validation
보령제약 Boryung
(Rank-No12)

Project: Boryung BIO Lab Building Clean room System Validation
동아제약 Dong-a
(Rank-No1)
Project: Cold Storage Room System Validation
보령제약 Boryung
(Rank-No12)

Project: Boryung BIO Lab Building Clean room Validation
동아제약 Dong-a
(Rank-No1)
Project: Cold Storage Room System Validation
한림제약 Hanlim
(Rank-No 36)
Project: MES Building Clean Room System Validation
동방FTL DongbangFTL
(Rank-No in top 50)
Project: Synthesis Building Clean Room Validation
청솔 바이오텍 Chungsol Bio Tech

Project: Synthesis Building Clean Room Validation
넨시스 Nensis

Project: Synthesis Building Clean Room Validation
글로벌제약 Grobal
(Rank-No in top 50)

Project: HVAC System Validation
보령제약 Boryung
(Rank-No12)

Project: Synthesis Building Clean room Validation
글로벌제약 Grobal
(Rank-No in top 50)

Project: HVAC System Validation
동아제약 Dong-a
(Rank-No1)
Project: Anticancer Building Clean room Validation
동아제약 Dong-a
(Rank-No1)
Project: Synthesis 2 Building Clean room Validation
동아제약 Dong-a
(Rank-No1)
Project: Synthesis 3 Building Clean room Validation
2008
2009
2010
2011
한림제약 Hanlim
(Rank-No 36)
Project: BMS System Validation (PC S/W)
2009
한국애보트 Abbott

Project: Cold Storage Room System Validation
한림제약 Hanlim
(Rank-No 36)
Project: Lab Building Clean Room System Validation
2010
2011
보령제약 Boryung
(Rank-No12)

Project: LAB
Building Clean room validation
2012
현대건설 HDEC
Project: HVAC System Clean Room Validation
2013
동방FTL DongbangFTL
(Rank-No in top 50)
Project: Sampling Clean room System Validation
Pharmaceutical, cosmetic industry is regulated by a variety of very strict (FDA, US FDA, WHO-GMP, EU-GMP, etc.) from a number of health authorities.
현재 한국 제약산업은 KFDA의 밸리데이션 요구를 충족시킬 만큼 자격이 있는 컨설턴트가 필요 합니다.

따라서 우수 의약품 제조 관리 기준(GMP, Good Manufacturing Practices)에
만족스러운 수준으로 부합하기란 결코 쉬운 과제가 아닙니다.
● S-TECH는 국내 및 국제 제약 시장에서 수행한 프로젝트 경험, 밸리데이션 기술, 정보 등을 바탕으로 국제 수준의 밸리데이션 & 품질관리 서비스를 제공할 것 입니다

● S-TECH는 한국 제약산업은 KFDA에서 요구하는 밸리데이션 요구에 충족시킬 자격을 갖춘 밸리데이션 컨설턴트를 제공할 것 입니다.
therefore to comply Manufacturing control standards superior pharmaceutical products (GMP, Good Manufacturing Practices) is not easy.
Currently, the pharmaceutical industry in Korea needs qualified consultants to fulfill the validation demands created by the KFDA.
S-TEHCH will provide qualified validation consultants to fulfill the validation demands created by the KFDA
S-TECH to respond to the needs of the market in support services and experience that can be validation from cover to design a long-term perspective.S-TECH will try cosmetic industries Korea Pharmaceutical to allow growth on a global level.
S-TECH will provide qualified validation consultants to fulfill the validation demands created by the KFDA
보령바이오 Boryung BIO
(Rank-No 12)

Project: Lab Building Clean room Validation
한림제약 Hanlim
(Rank-No 36)

Project:BMS System Validation (PC S/W) & Lab Building Clean room Validation

보령제약
(Rank-No 12)

Project: BIO Lab Building Clean room Validation
동아제약 Dong-a
(Rank-No 1)

Project: Cold Storage Room System Validation (PLC)
한림제약 Hanlim
(Rank-No 36)

Project: MES Building Clean room Validation
애보트코리아 Abbott
Project: Cold Storage Room System Validation
동방 FTL
(Rank-No in top 50)

Project: FTL Synthesis Building Clean room validation
청솔바이오택 Chungsol BIO Tech
Project: Synthesis Building Clean room validation

넨시스 Nensis
Project: Synthesis Building Clean room validation
글로벌 제약 Global
(Rank-No in top 50)
Project : Anticancer Building Clean room validation
보령제약 Boryung
(Rank-No 12)

Project: Synthesis Building Clean room validation
보령제약 Boryung
(Rank-No 12)

Project: Lab Building Clean room validation
글로벌 제약 Global
(Rank-No in top 50)
Project : HVAC System, PW System other 6ea Equipment Validation
동아제약 Dong-a
(Rank-No 1)

Project: Synthesis 3 Building Clean room validation
동아제약 Dong-a
(Rank-No 1)

Project: Anticancer Building Clean room validation
현대건설 HDEC
Project : HVAC System Validation
New factory that meets the requirements of cGMP and EU-GMP, Renovation related to the design review and overall consulting.
Manufacturing Support Equipment, Production equipment, Manufacturing Process for the Qualification and Validation Services (VMP, URS, DQ, IQ, OQ, PQ, PV, CV etc.)
S-Tech has a long-range view activity.Concept Design, as well as from EQ to CSV2013 according to the plan of the KFDA has a system that can proceed.

The ranking of pharmaceutical companies in Korea(Rank-No)
Full transcript