GMP 컨설팅

Validation Services 

·validation services typically include :

 - Equipment Qualification (DQ, IQ, OQ & PQ)

 - HVAC + LAF systems

 - Temperature / RH mapping

 - Water systems

 - Engineering equipment (Nitrogen / Air, DI water, steam systems)

 - Process validations

 - Cleaning validations

 - Microbiology - Related validations

 - Transport validations

 - Others

·Qualification stages :

 - Design qualification

 - Installation qualification

 - Operation qualification

 - Performance qualification

Commissioning(C) & Qualification(Q) 

- Manufacturing and Packaging Equipment

 - Maintenance System Qualification

 - Utilities Qualification

 - Facilities Qualification

 - FAT / SAT

 - Risk Assessment and Risk Management: Direct vs. Non-Direct Impact; Critical Vs. Non-Critical

 - Integrated Validation Approach

Risk-Based Approach for Qualification 

·Interpretation and Application of Quality Risk Management Guidelines (ASTM, ISO)

·Reduce test cases based on risk assessments

·Develop risk management exercises (e.g. FMEA)