Bioequivalence and Bioavailability Forum

Dear akinapally and Helmut
If you pass a GLP inspection your site gets a GLP certificate since this inspection focuses on your system whereas a GCP inspection focuses on a specific study in order to assess conditions, practices or processes that affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data. That's the big difference. As Helmut explained EU authorities can not issue such certificates as there is no legal base for this (see EMEA/INS/GCP/197226/2005). If you pass a GCP inspection it only tells you that the data obtained in the specific inspected study are valid and you will get an inspection report and nothing else.
Kind regards
Dan

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Edit: Document linked. [Helmut]