Hi Viraj,

I agree with your approach but I believe you can to the following points:

IQ – In addition to the manuals, you should call out maintenance and calibration schedules as well as procedural protocols for the entire process.

OQ- I believe the OQ should determine your maximum operational window for two things, the application of the antibiotic and the actual manufacturing hipstem as well.

PQ – No variability is inherently impossible. We can run a PQ with and acceptable risk assessed variability.

Otherwise this is a very good summary. Well done!