Bioequivalence and Bioavailability Forum

Hi ElMaestro!

Strongly support keelhauling.

❝ […] 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?

In my understanding you are targeting a main problem with GxP. From a historical perspective GxP (I think GLP was the first) the main idea was to prevent fraud. If everything is documented, you are able to reconstruct how a result was produced (yes, and why, by whom, etc). There's no scientific evaluation within GxP. If a procedure is bad science – but well documented – it is more likely GxP compliant than a genius’ badly documented work. If Fleming’s lab was not molding away during a vacation, we would not know penicillin. Do you think that Watson & Crick would have ‘survived’ a GLP-inspection?

I often hear ‘Well, we have an SOP for it!’ – but procedures in the SOP are bullshit from a scientific point of view. Remember a quote in one of our previous discussions. I always state ‘critical points’ not only in an SOP, but also in the protocol. So at least both the EC and regulators know what I indent to do. During an inspection IMHO you have better prospects for a procedure in an approved protocol, rather than an SOP only.