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Even when all is well at the facility, one must expect the worst while braving the elements.
"It was a snowy day," began our GMP Agent-In-Place. "The driver of the semitruck that was carrying our products from one of our distribution centers to another saw the truck skid ahead of him and slammed on the brakes. As a result, our truck jackknifed—hard enough to slice a hole in the trailer. The driver was okay, but due to the impact and the temperatures, the product was damaged. We ended up rejecting the $2.5-million worth of product that the truck contained."
Control, a senior compliance officer
"We were an old-line drugmaker," our GMP Agent-In-Place explained. "We still made some of our drugs from animal parts. One of the parts we used was the pork pituitary gland—it is a small gland within the skull of the pig, and we contracted with several large meatpacking companies to collect the gland for our company. It is not lucrative on the part of the meatpacking company because it requires the use of a specialized head-splitting device to cut the pig skull apart in order to collect the gland. Because only a few meatpackers had the device, we could not readily change our suppliers. When I asked about this, I learned that many of the head splitters were originally purchased by our company in the past and given to the meatpackers for use."
"We've had to deal with a recurring problem," said our GMP Agent-In-Place. "Some of our specialized lyophilization stoppers were not set properly on the vial and would tip off when the vial was moved to the lyophilizer, thereby losing the product within. When the problem became bad enough, we would call in the mechanic. Each time, the mechanic would fix the problem with the stopper setter. After a couple of fixes, we decided to see if we could prevent these occurrences, and as part of our investigation, we read the mechanic's notes. The notes said that the vacuum system used to set the stoppers was not releasing vacuum fast enough, and so the stopper would not be set properly. We ultimately corrected this with routine maintenance on the vacuum valves to prevent further loss of product. The maintenance period now occurs every quarter-year."
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.