Dear all,
we are planning a Phase I (FIH in Heathy Volunteers) with a new monoclonal antibody and we are evaluating the possibility the perform vial labelling and secondary packaging of the Drug Product at the investigator site, under the supervision of the clinical trials pharmacist and in presence of our Qualified Person allowing rapid final release of the Drug Product for Clinical Use. This should be mainly for allowing rapid and effective DP release and to avoid any additional logistic issue.
Really, we are approaching this situation because the manufacturer of Drug Product doesn't agree to send the filled inspected Drug Product in quarantine to the secondary packaging facility (another provider) before having the final Certificate of Analysis of Filled Inspected DP.
Do you know any regulation not allowing to manage the secondary packaging in quarantine? Have you any experience like this?
As alternative, do you think it's feasible to perform labelling and secondary packaging in the investigator site, under the supervision of the clinical trials pharmacist and in presence of our Qualified Person?
Have you already had an experience like this and /or have you any suggestion?
Best Regards
Stefano
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Stefano Porzio
CMC and Development Director
Enthera srl
Milano
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Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my
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