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GMP agents report on old products, aseptic violations, and unexpected emotions.
What expiration date?
"Imagine our surprise when we got a call from a hospital and they asked us what would happen if they infused a patient with a product that was nine years out of date," exclaims our GMP Agent-in-Place. "After a short while, it was clear that this was an after-the-fact call. We did explain that although we had not studied such administration in the clinic, we expected only a lack of efficacy, and the degradation products weren't known to be toxic."
"I worked as a quality control sampler who was sent into aseptic areas to conduct environmental monitoring," says our GMP Agent-in-Place. "We had a unisex sterile gowning room, and the sterile gowns were put on atop work clothes.
"One day, I needed to exit soon after the shift started, and met one of our quality control technicians in the gowning room. I'm not sure who was more surprised, she or I. She had stripped down to her underwear and was getting ready to put on her sterile gown. The environment in the aseptic area was warm, but wow!"
When it rains, contaminates pour
"It had rained and our roof had started leaking," says our GMP Agent-in-Place. "Our new maintenance manager was going from room to room trying to see how bad the leak was and wasn't paying much attention to where he was.
At the time, our equipment passthrough into the aseptic area had no security, so anyone could access this area through an adjacent unclassified hallway. Ignoring the posted signs on the door, the maintenance manager got walked all the way into the aseptic core before being noticed, until a very angry filling-machine operator had to physically push him out.
"Because of the potential contamination, the filling operation had to be stopped, any possibly affected product was discarded, and all sterile components had to be removed. Then a full clean-up, area disinfection, and restart was needed, creating a full day of backlog in filling."
Old becomes new
"Our product was manufactured in the United States and shipped to Europe," explains our GMP Agent-in-Place. "European laws required that the product be tested in Europe before release there. The European laboratory doing the old assay (OA) was going to shut down because it used animals and was out of favor. They had proposed to use a modern in vitro assay (MA) and the responsible Europe site applied to the European Union for a license change.
"But the application was made hastily because the contract laboratory hadn't actually made the MA work. Because they couldn't get the MA to work, the laboratory contracted out the OA to another laboratory, and then they reported the OA results on a certificate of analysis as an MA test result! Once we discovered this error, we amended (again) the European license back to the original OA but now by the alternate laboratory. We also had to explain this whole mess to the authorities, who weren't happy at all."
I laughed, I cried
"Company restructurings are hell," our GMP Agent-in-Place notes. "During one of them, I had to terminate six employees. This was a new experience for me, so I didn't know how it would affect me. Giving the first employee the news was very difficult for me. I nearly broke down and cried. The area supervisor was helping me and was sure I was having a nervous breakdown.
"Surprisingly quickly, I became inured to it, and could even see the funny side. During the termination of the sixth employee, I nearly laughed at the situation and it was all I could do to keep a straight face. No, it wasn't funny, but the emotional roller coaster was extreme that day. I never would have expected it."
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.