Pig parts"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."