Flipper, I don’t think an inspector would need to go to Sawston to inspect the Flaskworks manufacturing set-up. Sawston was recently GMP certified meaning that the MHRA inspectors previously looked at their GMP systems (quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling) in place to perform GMP manufacturing. So whatever modifications/enhancements they make the assumption is that it is done per GMPs since Sawston has the systems in place to do so. I also base this on a reference from Lykiri, and a revelation to me, that unlike the FDA, the MHRA does not do pre-approval inspections (I’ll have to go find that link again). Number 5 on your list is the biggie.
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