Hits and Strikes - Pharmaceutical Technology

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Hits and Strikes
Operators are hit hard by breakage problems and strike out on FDA inspections.


Pharmaceutical Technology
Volume 9, Issue 32, pp. 18

If it's broken, fix it

"After steam sterilization with a lot of sterile water for injection, we noticed an unusually large number of broken vials," notes our GMP Agent-in-Place. "It turns out that the old autoclave we used didn't have overpressure controls, and the vials experienced large pressure fluctuations that led to breakage. We investigated this, but FDA thought it wasn't thorough and handed us our heads over the issue.

"We recalled the lot, adding standard operating procedure controls specifying the percent of breakage allowed and providing detailed instructions about how to investigate such problems. Of course, the basic problem was that the equipment was not suitable for use, which was corrected when a new autoclave was installed a year later."

If it's not broken, DON'T fix it

"Our product barely made the expiration date. However, because it was an older, low-volume product, no one wanted to address this problem," reports our GMP Agent-in-Place. "But the problem did show up at the worst possible time: during a lengthy FDA inspection that I was hosting as the head of quality assurance.

"I was informed that the most recent batch placed on stability failed its six-month test point, and that the previous batch failed its nine-month test point. So we had to conduct this investigation while simultaneously handling the FDA inspection. Of course, the inspector then wanted the current stability data on the product in question!

"I bet you can guess that it's harder to investigate something with the FDA on site 'helping' you. We did the recall, but it was only after the FDA investigator left that we found out the raw material supplier had made a change in the final crystallization of the raw material without telling us. They made the change to make smaller particle sizes for this very potent drug substance, which it was sure its customers wanted. However, this change gave the particles more surface area, and because the substance is susceptible to moisture-related degradation, the material had an accelerated degradation profile. We got back into business with a return to the older crystallization method and with additional specifications for particle size on the drug substance."

Strike one

"I bet everyone has their favorite FDA inspection stories," our GMP Agent-in-Place notes. (And I would love to hear about your experiences, send them in!) "One of my favorites is that the FDA inspector showed up on the first day of a union employee strike at our facility. Because it was the first day, there were perhaps 100 employees demonstrating, showing their union colors and strength and of course blocking entrance to the facility. The inspector called in and questioned us as to what was going on. He stayed away during the strike, which is just as well because the non-union employees, including most of quality assurance, were now running the factory."

The new weight-loss program

"We bought certain natural raw materials from China. To set up the contracts, we sent two employees there to make the deals," says our GMP Agent-in-Place. "They went to a lot of very rural locations where Western food wasn't available. One of the two had a difficult time with the food, and ended up coming home 20 pounds lighter. It became a standing joke about the new purchasing department weight-loss 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
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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