What is the stability situation?

The technician sheepishly entered my office and sat down in the seat I offered. They came to tell me that samples pulled from the chamber three weeks ago had been set aside in our environmentally controlled staging area and not delivered to the lab for testing. They must’ve thought I’d be angry, but my only thoughts regarded the impact to the upcoming filing and how our systems had failed so dramatically. The problem was only discovered after regulatory affairs folk asked for the 1-month results and the lab had nothing for them, prompting a hunt for samples that LIMS said we had dispensed.

These samples were from the first interval of three accelerated (40/75) studies with 1, 2, 3 and 6-month pulls scheduled. The filing strategy hinges on availability of the 3-month data—long term and accelerated. Our procedure stipulates test initiation in two weeks and verification in 30 days for stability samples, so an investigation will be initiated since we’ve missed the first and almost certainly won’t meet the latter requirement.

Samples are being delivered to the lab and fingers are being pointed at the stability program (for good reason). A meeting will be held very soon, I’m sure, to evaluate impact and assess options for moving forward. They will want to know where systems broke down and how they will be fixed, but more importantly how we can salvage the integrity of the stability data in the eyes of regulators and future PAI inspectors.

How should this be resolved?

Even without systems in place, didn’t the labs know to expect the samples? Were QA folk not tracking this very closely? That said, since these are 40/75 samples and they’ve been stored presumably at controlled room temperature since being pulled from the chamber, the results should still be reported as 1-month data, in my opinion. Inspectors will be more interested in your systems now that this gap has been highlighted. How would you proceed?

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