Validation is the process of establishing documented evidence to ensure that systems and processes consistently perform as intended. It applies to analytical testing, equipment, facility systems (such as air, water, and steam), and critical processes including manufacturing, cleaning, sterilization, and sterile filling, in line with WHO guidelines.
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HEPA & ULPA filter integrity testing
Particle counting & contamination monitoring
Airflow pattern & distribution analysis
Air migration & containment verification
The Installation Qualification (IQ) protocol documents key details of each system or equipment, including identification, location, utilities, connections, and safety features. It verifies compliance with purchase specifications and ensures that all required documentation—such as drawings, manuals, spare parts lists, and vendor details—is complete and available, providing evidence that all components are properly installed and documented.
The Operational Qualification (OQ) protocol verifies that equipment or systems operate as intended under normal conditions. It includes testing of controls, alarms, switches, displays, and overall system functionality. The document outlines SOPs for operation, maintenance, and calibration, along with operator training requirements. It also defines test procedures, specifications, and acceptance criteria to ensure consistent and reliable system performance.
Performance Qualification (PQ) is conducted after the completion and approval of Installation and Operational Qualifications. It verifies that equipment or systems consistently perform according to required specifications under routine and, where applicable, worst-case conditions. The PQ document defines test procedures, acceptance criteria, and any preliminary requirements, ensuring that all supporting systems are validated for reliable and consistent performance.
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