Equipment Qualification & Validation
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
