Hi,
I would like to know what GxPs apply for activities of pre-clinical trial studies. Does the GMP also apply to these activities?
GMP applies to the manufacturing operations and for Pre clinical it is GLP and for clinical it is GCP.
GxP is the combination of all these three, together required for any drug development.
FDA GLP guidelines gives you the list of activities and regulatory documents needed during pre clinical.
Amudha