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GMP 컨설팅


Validation Services


·validation services typically include :

 - Equipment Qualification (DQ, IQ, OQ & PQ)

 - HVAC + LAF systems

 - Temperature / RH mapping

 - Water systems

 - Engineering equipment (Nitrogen / Air, DI water, steam systems)

 - Process validations

 - Cleaning validations

 - Microbiology - Related validations

 - Transport validations

 - Others


·Qualification stages :

 - Design qualification

 - Installation qualification

 - Operation qualification

 - Performance qualification


Commissioning(C) & Qualification(Q)


 - Manufacturing and Packaging Equipment

 - Maintenance System Qualification

 - Utilities Qualification

 - Facilities Qualification

 - FAT / SAT

 - Risk Assessment and Risk Management: Direct vs. Non-Direct Impact; Critical Vs. Non-Critical

 - Integrated Validation Approach


Risk-Based Approach for Qualification


·Interpretation and Application of Quality Risk Management Guidelines (ASTM, ISO)

·Reduce test cases based on risk assessments

·Develop risk management exercises (e.g. FMEA)

GMP 컨설팅

Validation Services 


·validation services typically include :

 - Equipment Qualification (DQ, IQ, OQ & PQ)

 - HVAC + LAF systems

 - Temperature / RH mapping

 - Water systems

 - Engineering equipment (Nitrogen / Air, DI water, steam systems)

 - Process validations

 - Cleaning validations

 - Microbiology - Related validations

 - Transport validations

 - Others


·Qualification stages :

 - Design qualification

 - Installation qualification

 - Operation qualification

 - Performance qualification

Commissioning(C) & Qualification(Q) 


- Manufacturing and Packaging Equipment

 - Maintenance System Qualification

 - Utilities Qualification

 - Facilities Qualification

 - FAT / SAT

 - Risk Assessment and Risk Management: Direct vs. Non-Direct Impact; Critical Vs. Non-Critical

 - Integrated Validation Approach

Risk-Based Approach for Qualification 


·Interpretation and Application of Quality Risk Management Guidelines (ASTM, ISO)

·Reduce test cases based on risk assessments

·Develop risk management exercises (e.g. FMEA)

견적문의
분야
견적문의
분야

CONTACT


대표자 : 이상건 | 사업자등록번호 : 454-81-00389

주소 : 경기도 안양시 동안구 경수대로651번길 58-2,

1층 (호계동)

Tel : 031-386-9433 | Fax : 031-386-9436

E-mail : hk@hkems.co.kr

한국이엠에스


GMP 컨설팅은 정확하고 완벽해야 합니다

제조환경 모니터링 분야에 다년간의 노하우로 그동안

축적된 기술력과 많은 고객사와의 신뢰를 바탕으로

GMP 컨설팅을 탁월하게 제공하고 있습니다.


CONTACT


대표자 : 이상건 | 사업자등록번호 : 454-81-00389

주소 : 경기도 안양시 동안구 경수대로651번길 58-2, 1층 (호계동)

Tel : 031-386-9433 | Fax : 031-386-9436

E-mail : hk@hkems.co.kr


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