3Q validation refers to Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). It is essential in industries with strict quality requirements, such as pharmaceuticals, medical devices, food and beverage, and biotechnology, for the following reasons:
Ensuring equipment meets design and regulatory requirements
Guaranteeing product quality and safety
Improving production efficiency and economic benefits
Meeting customer and regulatory requirements
Installation Qualification (IQ)
Document Review
Installation Environment Inspection
Component Installation Check
Operational Qualification (OQ)
Functional Testing
Parameter Range Verification
Safety System Testing
Performance Qualification (PQ)
Process Simulation Testing
Product Quality Inspection
Performance Stability Evaluation