- DESIGN QUALIFICATION (DQ)
- INSTALLATION QUALIFICATION (IQ)
- OPERATIONAL QUALIFICATION (OQ)
hanks to our professional know-how on pharmaceutical production processes and to the innovation brought to the company by our young and dynamic workforce, Unitech S.r.l. has developed a complete validation service for process plants:
● VMP and validation programs for processes, devices and plants, in line with current Good Manufacturing Practice regulations and the directives issued by major inspection association such as PDA, lSPE, FDA, EEC.
● Execution of ratification programs for critical production systems and support during lQ, OQ and PQ phases for devices, plants and pharmaceutical process analytical systems.
● Software validation.
● Assistance in producing the backup documentation for pharmaceutical production processes (SOP, FAT, SAT).
● Instrument checks and monitoring of environment variables (temperature, humidity, noise, pressure etc.).
Protocols and lQ/ OQ/ PQ activities for:
● Chemical hoods, laminar flow, biohazard areas.
● HVAC plants and clean rooms. WFI/PWCS production and distribution plants.
● Process equipment and machines.
● Preventive maintenance plans.
● Calibration of process instruments.
● Backup and assistance documentation.
● Measurements and instrument checks.
● Staff training.