"The focus of the animal research laboratory had changed," reports our Agent-In-Place. "The lab had started out focusing mainly
on large animal work in collaboration with a nearby University research station. As time went on, however, the large-animal
work halted, and the lab then focused on animal-based safety studies and LD50 studies for new medicinal drugs."
"I liked working with big animals, and because I was raised on a farm with big animals, I understood them. That was the work
that I had been hired on to do. Now, I was assigned to work on a study that involved mice, and it was completely new to me."
"One day, I slid open the door of the first cage to grab a mouse for examination. The other four curious mice all stuck their
heads out. I didn't want them to escape, and so I jammed the cage shut—unfortunately breaking their necks."
"The boss had seen this! Luckily, he only chuckled and said 'You don't have any problems working with the mice do you?' And
then he just walked away."
"I had just started at a new job at a large pharmaceutical manufacturing concern 1000 miles from anyone that I knew, and my
first paycheck was wrong," complains our Agent-In-Place. "The accounting department included a form showing how they calculated
the payment. Yeah, it was just a few dollars off, but it was my money and my first real job."
"When I complained, I was sent to an accounting clerk. The clerk tried to explain how she had calculated the payment, but
she was actually just reading the entries on the form. I tried several times to explain my position, but never got through
to her. I even shouted the less than tactful, 'Your damned form is wrong!' (I didn't know any better at the time.)"
"Realizing I wasn't getting anywhere, and not knowing where to turn, I went back to work without a favorable resolution. I
thought the money was gone for good. I was delighted six weeks later to receive the difference in dollars with a correction
check. It was my first real understanding of how the bureaucracy can beat you down."
Coat of silence
"The contracting company wasn't happy that they needed to recall the product because of a failure to maintain potency throughout
the shelf life," sighs our Agent-In-Place. "We had been manufacturing the coated tablet product for years, and had manufactured
it both for sales under our company name and under contract for the other firm. Our product wasn't being recalled."
"As coating technology changed and newer coatings became available, development work was completed for the product. Changes
were made only for the self-sold product, not the contracted product. Although both versions were stable throughout the shelf-life
if the coatings were intact, the older version tended to crack, causing an instability problem."
"When the instability problems came to light for the older version, the contract customers were forced into recalling their
product. In the end, their corrective action was to reduce the shelf life for their version. I don't think they ever really
understood that we used a newer and better coating process on our version."
"And please, don't you tell them now, 20 years later."
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 AgentinPlace@advanstar.com
We won't use any names, but if we do use your tale of disaster, courage, or just plain weirdness, Control will send you a
coveted Pharmaceutical Technology t-shirt.