As the title says, we found out we have been using a equipment without validation for past 4 years. It is very critical equipment that we use in GMP process. What would be our course of action now? We have used that machine frequently for last 4 years.
However, we have done regular quarterly calibration, yearly preventive maintenance and we do "day of use" calibration every time we use that equipment.
Can we do risk assessment now justify the previous years use and do new validation now for future use?
Please let me know your thoughts.
However, we have done regular quarterly calibration, yearly preventive maintenance and we do "day of use" calibration every time we use that equipment.
Can we do risk assessment now justify the previous years use and do new validation now for future use?
Please let me know your thoughts.