Bioequivalence and Bioavailability Forum

Dear AUClast,

❝ Do you agree on this interpretation ?

What I've heard EU regulators say is that some of the Member States (particularly UK) considered that GLP compliance was not sufficient when analysing clinical trial samples, and that GCP should be followed too, even at a lab. The UK also always had a rather strict approach to the scope of GLP, compared to some other Member States. This was the main reason for developing the recent EU Reflection Paper, which is based on a MHRA document: basically they put in a single document the relevant parts of GCP and of GLP. The wording in the EU BMV guideline is a compromise.

I think some of the Member States will stick to the paragraph in the BE guideline asking for GLP compliance when analysing BE trial samples, in addition to GCP. It would be safer to continue to have a declaration on GLP compliance in the report. After all, the BMV guideline does not say explicitly that no claim of GLP compliance is needed/expected

Regards
Ohlbe