In relation to pharmaceutical equipment, How would you identify 'critical design feature' of an equipment system that must be functionally verified prior to start-up

 

You identify 'critical design feature' of an equipment system that must be functionally verified prior to start-up by performing equipment qualifications(the actions of proving through recorded proof or evidences that any premise, system, and items of equipment work correctly and lead to expected results. These three qualifications must be written properly and effectively.

Installation qualifications (IQs). IQs demonstrate the process or equipment must meet all specifications, installed correctly, and all components that are required also the documentation that are needed for continuos operation are installed and also in place.

Operational qualifications (OQs). OQs are documents that shows the equipment is operating base on the manufacturer's specification. In here, critical parameters of the system/process are being tested. Critical parameters are commonly variables associated with system or equipment. Test data's and measurements should be documented correctly in order to set a baseline for the system or equipment.

Performance Qualifications (PQs). PQs is use to test the ability of the equipment to perform consistently over long period of time within the tolerance limit acceptable of the whole manufacturing process.