"Many years ago, we exported an over-the-counter liquid product in a plastic bottle to Japan," said our GMP Agent-In-Place. "We had sporadic complaints from our affiliate in Japan regarding bits of plastic in the product.
"As the particle findings became more frequent, our affiliate thought we weren't doing enough to solve the problem. They started their own investigation, beginning by dumping 10,000 bottles—yes, 10,000 bottles—through a sieve–screen. They found numerous tiny plastic pieces, slivers, and curls. Most of these were white like the bottles, but some were red and blue, and we never did determine their origin."Pet projects
"While I was a new employee at an animal-testing laboratory owned by a major pharmaceutical company, the union went on strike," recalls our GMP Agent-In-Place. "All the laboratory employees had to work additional jobs to cover for the union employees' six-week strike. Many of those who went on strike were cage washers and animal handlers. I was a statistician drafted into helping record weights and other weekly animal data for the ongoing studies. Three days a week, I was drafted to cover security during the second shift, in addition to my daily work.
"As a salaried employee, I received no additional pay. And it was boring beyond belief. I wouldn't have been able to stay awake except for my project," explained our agent. "I was building a Heathkit television and each night I would bring in my soldering iron, the blank circuit boards, and the electronic parts to my security desk. Thanks to the strike, I assembled my television much faster than I had expected.
"Another night watchman also had a pet project: he posted entries in the boiler- room log such as, 'I have killed another seven of the enemy flies. The others dare not enter,'" our agent laughed.
"Our company has manufacturing sites around the world," bragged our GMP Agent-In-Place. "But that can lead to local optimization. For instance, one site in Europe had a robotic system that would only work with pallets that did not have any bottom stringers. When the pallets arrived at the third-party logistics provider in the United States, the dock workers found out the hard way that the pallets were quite weak if nudged sideways during handling. In one case, the product tumbled, destroying $35,000 worth of product. In the end, the pallets were changed back to standard US 4-way pallets."
Gone, baby, gone
"In our Paris headquarters, the employees locked their offices even when going out for a smoke," said our GMP Agent-In-Place. "It seemed odd to me—we leave our US offices open all the time, even at night. On one occasion, a Paris employee left his office open during a trip to the toilet, and returned to find his computer gone. This was not a laptop, this was a full-size desk machine. Given the circumstances, it must have been another employee doing the stealing. But I always wondered how the thief removed the computer from the premises."
Weaseling out the information
"I was at an industry meeting last year, discussing unusual inspection occurrences," chuckled our GMP Agent-In-Place. "My new acquaintance said his company had recently undergone an inspection during which a weasel was seen in the warehouse. The tongue-in-check explanation given to the inspector was that the animal was part of the pest-control program."
Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer. If you have a story of clueless operators, oblivious management, inopportune lapses of judgment, or Murphy's Law in action, please send it to Control at [email protected]