"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
"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."