Bioequivalence and Bioavailability Forum

Dear ElMaestro,

First of all I am not familiar with ISO 17025, so I will not have an educated opinion on its merits.

❝ On the other hand bodies like EU/EMA and WHO enforce GLP explicitly for BE; GLP has existed longer than ISO 17025 and hence I might be inclined to think that bodies that enforce GLP do so for historical reasons rather than for scientific merits.

That's what I understood from a discussion with an EU regulator some years ago, when the previous version of the EU BE guideline was published and first asked for GLP compliance. At that time a large proportion of the BE trials submitted in Europe were still performed there. The CROs doing the bioanalytical work were also often involved in bioanalysis for preclinical safety studies, for which they had to follow GLP (no choice there, it was fully in the scope of GLP). A number of them also claimed GLP compliance for their BE trials. It made sense to ask the CROs to follow GLP for BE trials too, rather than recommend ISO, which would have resulted in a double reference system, and in a sudden raise in the suicide rate amongst QA staff.

Nowadays most trials submitted in the EU come from India and Canada, and few of these labs are involved in activities formally falling in the scope of OECD GLP (preclinical safety studies). It could make sense to give them a choice between GLP and ISO 17025, if this ISO norm is really suitable. I would say that one thing to keep in mind is that ISO is primarily a voluntary thing, while GLP compliance can be mandatory depending on the activities.