Business Fields

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Validation

Business Fields Validation

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.

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

PROCEDURE	TASK	OUTPUT
Conceptual Design	Conceptual Design Review of General Design Concept (Regulatory) about Lab Facilities	Project Implementation Plan Layout Personnel Flow Materials Flow Products Flow Waste Flow Air Flow Equipment Location Setup
Basic Design	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.	Review of Cross Contamination Air Flow Patten (dead Leg) Validation Master Plan
Detailed Design	Detail Design Risk Factor Analysis Criticality Analysis Process Risk Analysis Data Review	Impact Assessment Qualification Plan Risk Assessment User Requirement Specification

IMPLEMENTATION PHASE

PROCEDURE	TASK	OUTPUT
Construction	Establish Operation Plan Establish Quality Management Plan Design Review Manufacture Equipment or Build System	Design Review Design Qualification Risk Assessment
Basic Design	Factory Acceptance Test Punch List Functional Test System Functional Test Testing, Adjusting and Balancing	Factory Acceptance Test Functional Test

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