[Anonymous]

Reply To: Time Out of Storage / Refrigeration

From the OP: To date there is no cumulative tracking even before we have material packaged and released for study use. So if something happens to our drug product we aren’t tallying up the issue and duration of the pre-packed material along with the time out of refrigeration for packaging or anything that happens further downstream. In my past experience this was done on a lot level and we had to subtract from the total stability allowed time out of storage conditions every time we had some sort of event or exception. Here QA just puts out a generic memo for all lots with say “up to 30 degrees for 6 days” but nobody is adding it all up and we don’t have access to the paper based forms where they are writing up each event.

Part of the issue with our IP tracking is also that we have badly designed RTSM that doesn’t let us capture issues in transit to sites or at sites. But, even if we did, nobody is adding it all up from the last material phase change to be sure. In some cases we have biologics and others small molecule solid oral dosage forms. Our capsules for example are sometimes just powder in a shell with no other fillers blends or other formulation, so in that case even the API exposures prior to manufacturing is important. I would feel better if we switched to blisters instead of bottles but that is a story for another day.

Regarding temperature cycling studies, we don’t have these. We do bare minimum ICH standard time points and don’t even go to zero C for all of our cold chain products. It is a struggle to get a timepoint added to the plan even when we need it for expiry management reasons.