As the importance of validation and qualification is continuously required and the high-quality final products (medicine, etc.) is demanded in the bio and pharmaceutical industry, the demand for RM (Risk Management) and DR (Design Review) is rapidly increased beyond the past simple IQ (Installation Qualification) and OQ (Operational Qualification).
Therefore, GCEM executes DQ (Design Qualification), IQ (Installation Qualification) and OQ (Operational Qualification) and provides risk management service based on risk analysis.

Design Stage
PLANNING PHASE
  • P
    R
    O
    C
    E
    D
    U
    R
    E
    • As-Is
      Analysis
    • To-Be
      Planning
    • Require-
      ments
  • T
    A
    S
    K
    • Preparation for Process Definition & Design
    • Review of Process Validity
    • Preparation Basic Resources about Critical Parameter and Controls
    • Whether to Secure Legitimacy about Specification Criteria
    • Setup of GMP Operation System
    • GMP Organization
    • Master Plan Planning &
      Criterion of Utility &
      Equipment
    • Establish Criterion of Validation
    • Criterion of Boundary of
      Automation
    • Preparation Master plan
  • O
    U
    T
    P
    U
    T
    • Setup of Project Scope
    • Milestones
    • Setup of Operation System
    • Establish Requirements for Equipment
    • Establish Requirements for Automated Facilities
    • Establish Requirements for Utilities
    • Establish Requirements of Validation
    • Calculation of Process, Expected Price and Estimated Amounts
    • Analysis of Requirements
DESIGN PHASE
  • P
    R
    O
    C
    E
    D
    U
    R
    E
    • Conceptual Design
    • Basic Design
    • Detailed Design
  • T
    A
    S
    K
    • Conceptual Design
    • Review of General Design Concept (Regulatory) about Lab Facilities
    • Basic Design
    • Review of Installation Condition and Flow Pattern of Production Facility, Equipment and Utilities in terms of Regulatory Criteria, Product Nix-up, Contamination, Process Segregation, etc.
    • Detailed Design
    • Risk Factor Analysis
    • Criticality Analysis
    • Process Risk Analysis
    • Data Review
  • O
    U
    T
    P
    U
    T
    • Project Implementation Plan
    • Layout
    • Personnel Flow
    • Materials Flow
    • Products Flow
    • Waste Flow
    • Air Flow
    • Equipment Location Setup
    • Review of Cross Contamination
    • Air Flow Patten (dead Leg)
    • Validation Master Plan
    • Impact Assessment
    • Qualification Plan
    • Risk Assessment
    • User Requirement Specification
IMPLEMENTATION PHASE
  • P
    R
    O
    C
    E
    D
    U
    R
    E
    • Construction
    • Basic Design
  • T
    A
    S
    K
    • Establish Operation Plan
    • Establish Quality Management Plan
    • Design Review
    • Manufacture Equipment or Build System
    • Factory Acceptance
      Test
    • Punch List
    • Functional Test
    • System Functional
      Test
    • Testing, Adjusting
      and Balancing
  • O
    U
    T
    P
    U
    T
    • Design Review
    • Design Qualification
    • Risk Assessment
    • Factory Acceptance Test
    • Functional Test
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