Equipment qualification

Evaluating User Requirements Specification (URS) for the equipment to be purchased, checking that equipment characteristics and capacity meet the requirements of the manufacturing process; 

Supporting and monitoring manufacturing processes and equipment supply;  

Verifying manufacturer's documentation; 

Checking equipment appearance and labeling; 

Verifying that equipment configuration meet specifications, checking that equipment is installed correctly against its installation drawings; 

Ensuring that materials comply with GMP; 

Obtaining the documented evidence that the equipment operates properly and emergency, interlock and alarm systems perform efficiently; 

Monitoring efficiency of control systems; 

Ensuring that measuring devices are reading correctly (monitoring of calibration of critical instruments); 

Monitoring reliability and reproducibility of critical parameters, including the worst-case scenario. 

DQ (Design qualification); 

IQ (Installation qualification); 

OQ (Operation qualification); 

PQ (Performance qualification). 

Qualification of steam sterilizers; 

Qualification of autoclaves; 

Qualification of depyrogenation; 

Qualification of depyrogenation tunnels; 

Qualification of dry heat ovens and dry heat sterilization; 

Qualification of chemical sterilization; 

Qualification of Eto sterilizers; 

Qualification of ethylene oxide sterilizers; 

Qualification of reactors; 

Qualification of mixers; 

Qualification of tanks; 

Qualification of filtration systems. 

Aseptic systems; 

Reactors, tanks and other vessels; 

Fermenters, equipment used in biopharmaceutical manufacturing; 

Sterile filtration systems; 

Washing lines - sterilization/depyrogenation - filling - capping; 

Freeze dryers; 

Steam/irrigation sterilizers for the sterilization of finished products and materials; 

Equipment used in manufacturing prefilled syringes; 

Bottle-puck lines; 

Inspection machines; 

Leak testing machines. 

Tablet Manufacture (presses, mixers, granulators, dryers, coaters, etc.); 

Suppository, capsule and tube-filling machines; 

Equipment used in the manufacture of aerosols and sprays; 

Syrup lines; 

Powder filling machines. 

Carton packing machines; 

Blister packing machines; 

Labeling machines; 

Thermostats, incubators, hot air sterilizers and hot-air ovens; 

Laboratory sterilizers; 

Cold chambers, freezers and environmental chambers; 

Equipment for pharmacotesting; 

Isolators, laminar flow cabinets and biological safety cabinets.