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​주요서비스

Inquiry

​문의

Procedure

계획

Task

수행

Report

보고

Solution

결과

Conceptual Design
Execution or Review
GMP Consulting
GEP Consulting
Validation Consulting

  • Project & Organization

  • Project & Validation Strategy Consulting


     

1.
Planning Supporting

  • Conceptual Design

  • Process Analysis



2.
Conceptual Design Study

  • VMP Development

  • System impact Assessment

  • Validation System

  • Risk Assessment
     

3.
Validation Strategy

  • URS Development

  • DQ, IQ, OQ, PQ Execution

  • PDI Execution

  • Design Risk Assessment

  • Requalification

4.
Qualification Consulting

  • Process Validation

  • Cleaning Validation

  • CSV

  • Analytical Procedure Validation

  • SOPs Development

5.
Validation Consulting

  • Revalidation

  • Quality System

  • Change Control

  • CAPA

  • Document Control

6.
GMP Consulting

GMP Consulting

  • GEP Project Planning

​


 

1.
Planning Supporting

  • Quality Planning

  • Project Master & Planning

     

2.
Engineering Planning Consultion

  • FDS Development

  • Basic & Detail Design Review


     

3.
Design Review

  • GMP Supervision

  • FAT Service

  • EM Supporting

  • Commissioning

  • SAT Service

4.
Commissioning Consulting

  • Calibration Service

  • Maintenance Service


     

5.
Preventive Mainternance

GEP Consulting

1. Installation & Operational Qualification

2. Performance Qualification
 

3. Cleaning Validation (세척)
 

4. Process Validation
 

5. Computerized System Validation

6. Re-qualification & Re-Validation

7. Transfer (운송)
 

8. Method (방법)
 

9. Packing (포장)
 

10. Sterilized (멸균)
 

Validation Consulting

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