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Validation

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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
PROCEDURE
TASK
OUTPUT
  • As-Is Analysis
  • Preparation for Process Definition &
    Design
  • Review of Process Validity
  • Preparation Basic Resources
    about Critical Parameter and
    Controls
  • Whether to Secure Legitimacy about
    Specification Criteria
  • Establish Project Scope
  • To-Be Planning
  • 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
  • Milestones
  • Setup of Operation System
  • Establish Requirements for Equipment
  • Establish Requirements for
    Automated Facilities
  • Establish Requirements for Utilities
  • Establish Requirements of Validation
  • Requirements
  • Calculation of Process, Expected
    Price and Estimated Amounts
  • Analysis of Requirements
DESIGN PHASE