Bioequivalence and Bioavailability Forum

Hi all,

I have been asked to give some input to regulators in the ASEAN region about issues relating to bioanalytical quality standards.
One potentially hot potato is Good Laboratory Practice vs. ISO 17025, and I'd like to hear some opinions, pros and cons for these standards. GLP can be further subdivided into OECD, EPA and 21CFR58, but I think we can disregard EPA and 21CFR58 here.

My own present opinion:
From a science perspective I think the ISO standard is a bit more relevant to BE bioanalysis than GLP. The clauses of ISO are by nature more concretely relating to bioanalysis and hence easier to relate to for lab personnel, QC people and even evil and ugly auditors like myself. The scope of the OECD GLP guidance is worded borderline problematically, and hence many aspects rely on heavy interpretation of some general clauses. I have not come across any GLP observation that could not be translated into a corresponding ISO17025 observation. Thus I believe that ISO 17025 has some scientific advantages over GLP. 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.

I would very much welcome some opinions both from those who favor GLP and from those who favour ISO 17025. And if you happen to know some other standard which has some potential advantages over GLP and ISO then by all means educate me, please.

Thanks for any input in advance.