"It's easy to make a mistake," declared our GMP Agent-In-Place, "especially if you don't read the specification when printing the expiration date on the label. We had used the same 42-month expiration date on our product for years, but it had recently been reduced to 36 months. The packaging supervisor didn't think to look up the date because she thought she knew what it should be. The quality inspector and quality release officer did the same thing. Luckily, the product was a diluent that had to be packaged with another product. During that packaging, we found the error," sighed our Agent. "Although no incorrect product was distributed, we had to relabel three lots of diluent and were two weeks late in delivering our combination package."
All broken up"We received several broken-vial complaints from the US marketplace about our newly introduced product," our GMP Agent-In-Place complained. "The product was sold in several European countries as well, but no complaints came from there. My European colleagues were convinced that the problem was the shipping materials we used in the US, and they performed an analysis demonstrating that pressure inside the vial was causing the glass to break. Clearly, they claimed, temperature was the issue, and the –20 °C gelpacks were the root cause.
"The product was sold in packs of 10 that looked like an egg carton, except that there was glass-to-glass contact inside the pack," our Agent went on. "To me, the packaging seemed to be a more likely source of damage, especially because the packages are shipped by overnight air where they go through a large tumbler during the sorting process at the central air-express facility. I explained this to my European colleagues and asked them to research the product's freezing-point depression. It was a viscous solution with a 7 °C depression. In addition, I knew that small vials tend to be quite resistant to breakage from freezing. The Europeans peformed more tests using the actual cold box we used in the US. They found that even with fresh-from-the-freezer gel packs, the internal temperatures were still warmer than the freezing point for the product. They finally agreed that the glass breakage was caused by a combination of the glass-to-glass contact in the pack and the rough handling of our air-express vendor. We now sell the vials in individual cartons."
"We had a three-day meeting planned in Germany, and I made my travel arrangements ahead of time," began our GMP Agent-In-place. "Two weeks later (and two weeks before the trip), my boss asked me to stay in town another two days to perform a quick audit of some new equipment. That was all well and good," sighed our agent, "but two days before I was supposed to fly to Germany, my boss asked me to stay yet another day—and into the next week for a last-minute meeting regarding quality concerns. My ticket-change fees were more than $1000."
"We received a complaint about a red piece of plastic in our product," described our GMP Agent-in-Place. "When we analyzed the plastic, we realized that it was a piece of the plastic flip-off seal. Our customer had neglected to remove the plastic seal before puncturing the stopper with a needle, and pushed a bit of the seal into the vial. Of course, they never admitted the mistake to us."
"As a senior supplier auditor, I audit the suppliers within driving distance of our facility using my own car," our GMP Agent-In-Place explained. "One supplier received its raw material in polyethylene drums. When I asked what they did with the empty drums, they replied that they give them to a local recycler. Because there was no money involved, I asked for a couple of drums to use as rain barrels. They barely fit into my car as I was 'barreling' down the highway."
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]