Getting Personal - Pharmaceutical Technology

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Getting Personal
Cautionary tales from the files of "Control"


Pharmaceutical Technology

Acting up



"The company was nearly shut down by FDA after a disastrous inspection," our GMP Agent-In-Place relates. "After several resignations and terminations, remaining staffers were bumped up into 'Acting' positions. So, my ambitious same-level colleague was now Acting—and was he ever!

"I was an early user of the first Palm Pilot, and not very many people had one or understood what it could do. I used it to take notes while walking around, especially if I was nabbed for a short stand-up meeting in the hallway. Suddenly, three different vice-presidents came to call and told me to be respectful of 'Acting.' The third one said, 'He says you are playing with a calculator when he speaks to you.' Finally, I understood what was going on. 'Acting' thought I was not paying attention, even though I had diligently been taking notes and action assignments and later following up on them. Apparently, 'Acting' had never heard of Palm Pilots or seen them in action."

While the cat's away

"We were a new department at a manufacturing site, three young statisticians, just out of college with a 30-something boss," remembers our GMP Agent-In-Place. "The boss resigned for a bigger position in a bigger town, and we were left bossless.

"So we did what all young employees without adequate supervision do: We took longer breaks and played cards. In our defense, we weren't the only ones to play cards, but we were the loudest.

"Soon enough, department management was notified, and we were called in for a general thumping. Although the manager said it was the overlong breaks that were the issue, his long-winded berating made it clear that it was the loudness that really got us into trouble."

Lullaby and goodnight

"When you have a new quality director, everyone wants to know what he or she is like," says our GMP Agent-In-Place. "Because my cubicle was right outside the director's office, everyone asked me. At first, I didn't have much to say, but then I noticed she would nod off at her desk occasionally, and others reported seeing the same during meetings. It turned out she had narcolepsy.

"She would borrow a cup of coffee from our unit's pot. We didn't mind because if we kept the boss happy, she might cut us some slack. But our secretary decided we were too hyper and switched to decaf without telling anyone! She didn't know the boss was drinking our coffee.

"The boss was mad when she found out! She knew that she was dozing more often, but didn't know why."

IT wasn't helpful

"Our million square-foot pharmaceutical factory had some serious problems with the computer systems supporting the quality control department, and a large meeting was called," recounts our GMP Agent-In-Place. "Even the quality vice-president from corporate came in for the meeting. Instead of coming himself, the head of IT sent the systems analyst who was in charge of supporting quality control systems with a half-page statement to read. The systems analyst read the statement and then left. There could be no discussion or decision making."

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
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.

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