Hi All,

After viewing the lecture for this week, I have thought about the IQ, OQ, and PQ for the Syringe Filling Process – filling syringes with an injectible bone void filler.

IQ – meets specs including the amount of bone void filler added to each syringe; the amount of bone void filler fills the syringe; maximum and minimum filling points, use-by dates, and pressures at which syringe is filled; has specific SOP for filling the syringe; scheduled measurements of filling taken to ensure calibration

OQ – ensuring that each syringe is filled within the min/max range with bone void filler; finds the min/max pressures that syringe is filled up with and set as control limits

PQ – running the syringe filling process multiple times, with multiple vendors and show that variability is the same throughout

-Andrew Nashed