Reply To: Site to Site IP Transfers: Approvals and Release

[Steven Jacobs]

Reply To: Site to Site IP Transfers: Approvals and Release

Hi,
First off, you should have an SOP in place if you decide to do site to site IMP transfers.
Make sure quality is built into the process (ICH Q8 guidance) so you’re not sending material that’s not GMP compliant.

That usually means that you would need all documentation to show the material was within temperature spec for the entire time it was:
1.) shipped to the original site
2.) at the clinical site before it’s shipped to the new site (and optionally)
3.) shipped from the original site to the new site

Consider that part of your process includes a review and sign of by QA to release the IMP before it moves to the new clinical site.
Steve