Shielding Shoddy Shipping

We just started shipping our room temperature inhalers to a new market in a Zone IVb climate, but it’s not going well with environmental control. It seems like each week we’re getting at least two calls to OK a shipment after temperature excursions occurred on route. We’ve been “helping out” by explaining how the levels are within the range of accelerated temperature data we have, or in some cases, not too far outside and we give our opinion that the shipment will be OK. This is not something we are well-equipped to do, and clearly are not doing very well.

I’ve notified upper management of our responses and of the compliance danger if our assessment is ever questioned in an audit. My boss and his boss are supportive, but there’s a huge disagreement with QA and Shipping now. I’m being pushed to back up our position with guidelines and data, and to propose a feasible path forward to both eliminate future compliance risks and these excursions altogether. Here in manufacturing QA we only have data from our primary and commercial studies, so where do I start on this quest?

I was thinking that I should get R&D involved to build a “stability budget” from the pre-approval and post-approval data already on hand. In my opinion, they should have been the ones scientifically justifying these excursions all along. It may be expensive if additional studies are needed, but we desperately need to get these current and past excursions properly supported before we end up with a recall.