Equipment qualification

Our company offers a full range of services: preparation of User Requirements Specification (URS) for the equipment to be purchased, equipment qualification, carrying out PQ/PV (performance qualification/process validation) stages. 

Equipment qualification is documented evidence that the equipment complies with GMPperforms within the specified operating ranges and is suitable for manufacturing products of the required quality. 

Equipment qualification includes the following activities: 

  • Evaluating User Requirements Specification (URS) for the equipment to be purchasedchecking 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 specificationschecking 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. 

Equipment qualification, stages: 

  • DQ (Design qualification); 

  • IQ (Installation qualification); 

  • OQ (Operation qualification); 

  • PQ (Performance qualification). 

Qualification of pharmaceutical equipment may include: 

  • 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. 

We carry out the qualification of the following equipment: 

Qualification of equipment for manufacturing STERILE pharmaceutical products: 

  • 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. 

Qualification of equipment for manufacturing NON-STERILE pharmaceutical products: 

  • 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. 

Qualification of packaging equipment: 

  • Carton packing machines; 

  • Blister packing machines; 

  • Labeling machines; 

Qualification of equipment for R&D / QA laboratories: 

  • 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. 

Qualification of manufacturing equipment of medicines, packing machines and R & D / QA Laboratories with GMP standard

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