Bioequivalence and Bioavailability Forum

❝ Or maybe just their PC's system clock needs an overhaul?

Or maybe 'someone' in that company needs a keelhaul? I don't think any of WHO's documents specifically forbid using keelhauling as corrective action.

Re. section 5 where ref. is made to §6.7 "The method validation ... not be ensured"
I fully agree. In principle there is, as I see it, an element of scientific assessment in that statement. The problem here is perhaps not necessarily (lack of) compliance with some internal procedures but rather bad science. To generalise my point, if a company is compliant with its procedures but the procedures are bad, is this then a GxP issue or is it something else?


Best regards
EM.