[Aaron Staff]

Reply To: Accelerating Phase 1 timelines as much as possible

Shipping unlabeled britestock is challenging internally with your QA – they may need to perform additional steps before shipping to a final use facility which are usually done when your drug product becomes IMP. Don’t assume that it is as easy to ship nude vials for your QA as it is to ship IMP.

Also, is the phase 1 unit in the same country as the product is or is it in the EU? Shipping internationally means that you need to get through customs and may have to have your IND/IMPD filed which requires pictures of the labels in some cases which means they check for your product to have those labels when they come into the country. Shipping into the EU, means you need QP release and your product won’t be labeled, so consult your QP before you take a step.

Depending on the country where your phase I unit is, there may be mfg requirements that pharmacies may not have to label in a particular country. Make sure you fully understand that or it kills you before you stumble through all the problems above. IF you are using a Phase 1 unit, someone may have done this before at their facility. Please ask them if they can do what you want to see if they have good or bad stories.

i am listing challenges and problems, because I haven’t tried your scenario. I can’t give you an example of it working, but I can guess where things can go wrong. It is very challenging to get IMP labeled and delivered when you have an IND and protocol. These examples of issues I have experienced in regards to attempting to do just that or when someone tried to get around some steps.

Remember that if this is phase I for a new product, your CMC team may not have all the answers which are needed to get your product through customs. Moving materials which don’t have a lot of stability or where the manufacturer is external means a lot of stresses on your shipping group. Work with them from the beginning to assure that CofA’s, CofC’s, etc. are good as I expect most of your challenges will be shipping the material to the site instead of having it labeled by someone else and then shipped to the site. Sometimes, the time you spend labeling allows you CMC and QA teams to do the needful to get you to your site easily.