Bioequivalence and Bioavailability Forum

Dear Dr_Dan,

❝ If you pass a GLP inspection your site gets a GLP certificate since this inspection focuses on your system whereas a GCP inspection focuses on a specific study in order to assess conditions, practices or processes that affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data. That's the big difference.

I agree but I see one additional level of complexity. I think we need to distinguish between system inspections and study inspections, and certifying bodies versus non-certifying bodies.
If a lab passes the inspection from a certifying body then, yes, a GLP certifcate may be issued. The inspection will be of the system type, but the inspector is of course likely to ask for specific examples from studies along the way. In some countries GLP inspectors are only available from the certifying bodies which may not have anything to do with the Drug Agency. Sometimes drug agencies have their own GLP inspectors who accordingly don't certify the labs but 'just' inspect them.
Most (all??) EU GCP inspections at the moment are study-linked, but the same is not the case with FDA inspections, I think. FDA also do GCP system audits. Along the same lines I don't think the EU statutes provide for non-system GCP inspection only. System GCP insps are possible but rare, perhaps due to budget constraints?!

Finally, on basis of recent experience from my audits I hafta say that if I had 17 trillion billion euros that I could donate to good causes then GLP/GCP inspection at NMA's would receive a fairly decent portion.