Bioequivalence and Bioavailability Forum

Hi,

For bioanalytical laboratories, is it really GCP applies?

In the draft EMA BMV guidelines, it was stated that bioanalytical method validation should be performed in accordance with the principles of "Good Laboratory Practice (GLP)".

Where as in the Final EMA BMV guidelines, it was stated that validation of bioanalytical methods and the analysis of study samples for clinical trials in humans should be performed following the principles of "Good Clinical Practice (GCP)" and even in the subsequent reflection paper also.

However, some of the regulatory agencies like Thailand are issuing the GLP certification for the bioanalytical labs.

Hope to get clarity in the expected (this year) BMV guidelines from US FDA.

Regards,

Debbie.