Primary Packaging Pressure Pickle

We’re approaching clinical trials for our solid dose antihistamine type medication packaged in blisters. All developmental stability studies were performed in an Aclar blister with foil backing from suppliers we are familiar with for our other product lines. Now procurement is pushing to change suppliers (more local and diverse), insisting that the alternative is identical with the same type of Aclar resin. To expedite time to market, the plan being pushed is to initiate clinicals and primary stability simultaneously, mind you, without any new extractable or leachable studies. A justification, primarily arguing for equivalency will be included in the filing.

As the director of quality, including the stability program, it seems up to me to put the brakes on what could be a very harmful decision—at the very least harmful to commercialization but possibly even to the clinical participants. In my presentation to the development gating committee (the group approving initiation of clinical trials) I want to give a fair and balanced stability risk assessment.

What are some key points I should focus on to get the most impact from my presentation?

At the very least there must have been some sort of supplier qualifications performed for these local vendors. It’s hard to believe they would not have used this proposed new packaging and compared it to the previous data with some stability study. If not, then you are looking at a 483 simply for not properly qualifying this supplier. That alone should put the brakes on.