FDA Pharmaceutical Qualification Services

AIME qualification procedure

In a typical inspection process, the physical defect set is reloaded each time a revised recipe is analyzed. This produces different images, which could produce different results even if no changes are make in the inspection recipe. With the AIME system in place, the qualification module saves images during the initial qualification. Reprocessing the saved images with a revised recipe shows the true impact of recipe modification without requiring line time for testing.

Prime Results qualification services begin with an evaluation of your existing process.  We then determine what tools of ours will be the best fit.  The ideal point to begin designing new equipment qualification is prior to writing the URS.  With upfront planning, you can be assured of no surprises or gaps between your quality department’s expectations and the delivered performance from your selected machine. Our qualification services are also available for existing lines where a continuous improvement capability can be added into the qualification procedure.  When designed properly, the continuous improvement cycle can be implemented requiring minimal line time, increasing overall throughput.