Our Advantages:

We offer high-efficiency and high-quality services to Qualification and Validation, organized experts from cGMP, IT, engineering technology and test area (KNOW-HOW).

Services:

• Validation master plan

• Equipment adjusting plan

• Cleaning validation

• Process validation (QbD)

• Mock filling

• Calibration

• Qualification (IQ, OQ, PQ)

• FAT/SAT

• Checklist for equipment and process

• Impact & market assessment 

• Risk assessment

• User requirement specification (URS)

• Technology transfer

• Validation testing service

   

  Process equipment

• Sterilizers

• Ampules and Vials filling line

• Oral products manufacturing equipment

• Freeze - drying system

• Secondary packaging equipment

• Reactors

• Isolators & Glove boxes

• Light check machine

• Tablet check machine

• Filter driers

• Mill

• Blistering Machine, and etc.

Utilities

• HVAC

• Clean rooms

• Process fluids systems

• Laminar flow systems

• Water system (Water for Injection, Purified Water, Pure Steam)

   

  Process control systems

• Environmental condition monitoring system

• SCADA

• DCS (Distribution Control Systems)

• ERP