Bioequivalence and Bioavailability Forum

Dear ElMaestro,

❝ 5a: Does this mean GAMP principles are enforced for inspectors?

My understanding of this document is just that the inspectors announce that they will use the PIC/S guidance as a reference during their inspections.

❝ If yes:

❝ 5b: Does that imply sponsors need to observe principles from GAMP for clinical trial software?

That would be a very, very weak legal basis: GCP say that the computerised systems used by sponsors should be validated, but state nowhere that validated means GAMP- or PIC/S compliant. Pretending that this single sentence at the bottom of a one-page document, not endorsed by the CHMP and which nobody can find unless they know it exists (or clicked on every single link on the BEBAC guidance page) is sufficient to make it an official reference text would make any lawyer start licking his lips.

❝ If yes:

❝ 5c: When I was a regulator I thought any and all principles that regulators want sponsors or stakeholders to follow is and will be accessible free of charge.

You only worked with medicinal products at that time... Look at the medical devices world: ISO norms everywhere, all coming for a fee, even the GCP norm...

❝ Can EU regulators enforce principles that are not in the public domain, free of charge, and will they really do so?

No they will not: they won't have access to the text themselves (no budget)
(Except the MHRA, but that's only EU for the next couple of months).