Hi All,
I feel that system impact assessments to determine if equipment/systems can be quite targeted towards manufacturing equipment/systems more so than laboratory equipment/systems. Can you give advice as to how I could define an SIA to target lab equipment/systems? Thanks
In general, a SIA introduces the impact of a lab instrument on the quality of a drug product and the detriment if it is not working properly. The solution is to calibrate the instrument over a range (matrix) likely to be encountered with a traceable standard (NIST in the USA).