Interruptible power supply
"We are connected to an uninterruptible power supply (UPS)," our GMP Agent-In-Place complained. "When the power went off on
our lyophilizer, the UPS should have kicked in immediately. We had $1 million of product in the lyophilizer that was at risk,
so the UPS was a good idea. However, on one occasion, the UPS failed to kick in, and as a result of the power outage, the
lyophilizer compressors stopped cooling the shelves, and the shelves no longer met the cold temperature requirement. This
happened after midnight on a Saturday, so we needed to notify mechanics and experts. It took nearly 13 hours to correct, so
we had a deviation of major proportions. We soon replaced the UPS because the existing one was malfunctioning. The batch had
to undergo significant laboratory and technical evaluation before being considered for release."
Lack of product stability
"We purchased product from another company," explained our GMP Agent-In-Place. "The product had a room temperature allowance
within the usual refrigerated storage requirement. The idea is that the patient could store the product on their counter rather
than in a refrigerator. The other company made a change to the stabilizer of the product and their stability studies seemed
to show there was no change in product stability. Unfortunately, after we started distribution of the new formula, additional
stability data showed the formula would not meet the room temperature allowance and we had to recall several batches. The
reason for the delayed information was that the assay for the product was quite variable with a coefficient of variation of
7%. This variability hid the true stability for some time, and we paid the price."
Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the files of Control, a senior compliance officer.
If you have a story to share, please email it to Control at AgentinPlace@advanstar.com
We won't use any names, but if we do use your experience in the column, you'll receive a Pharmaceutical Technology t-shirt.