Organization

Organization Structure

GMP Consulting & Engineering Specialist Group

CEO 대표이사
CFO 재무이사
Site Develop

Conceptual Design

  • Clean Room & Utility System Layout
  • Equipment Layout
  • Clean Device Layout
  • Material & People Flow
  • Feasibility Study
Qualification, Validation

GMP Activity

  • Validation Master Plan (VMP)
  • Urser Requirement Specification (URS)
  • Risk Assessment (RA)
  • Qualification (DQ/IQ/OQ/PQ/RQ)
  • Validation
Audit /GMP Document

GMP Consulting

  • Gap Analysis & Audits
  • QMS Development & SOPs
  • Third-Party Audit Support
  • Regulatory Submission(EMA/FDA)