Balancing Act - Pharmaceutical Technology

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Balancing Act
Remaining calm, cool, and collected during mergers and inspections is a feat in itself.


Pharmaceutical Technology
pp. 16

A rose by any other name

"We sold a huge amount of a commonly used prescription medicine in several strengths. The product came in brightly color-coded tablets, including a rose color," our GMP Agent-In-Place explained. "We received quite a few complaints that the product was ineffective and quickly learned to test for counterfeiting—the most common root cause for the complaints. The counterfeit version looked accurate and even had our trademark name printed on the top of the tablets, but the fake products did not have the correct active ingredients and thus, were ineffective."

Needled out of a recall

"The complaint came from a hospital in Mexico City to our facility in Mexico, where I was the head of quality," recalled our GMP Agent-In-Place. "The hospital had identified clear contamination of a controlled-substance injectable. They simultaneously notified the Mexican Health Authorities, who were hot on our case to recall the batch.

"Our retain samples, however, did not show any visible contamination, and the release sterility test passed as well. So we initially thought the product had been contaminated by an outside source," our Agent continued. "But the aluminum tear-off seal was still intact, making that possibility unlikely. We knew we would have only one chance to prove entry before we opened the vial in question for testing. Our microbiologist examined the seal under a microscope, and could see a very small dent near the tab that is used to tear the seal off. Through the seal was a dimple in the stopper. We immediately contacted the health authorities and sent them pictures of what we had discovered.

"They came to see the specimen in person, and together, we removed the seal and saw the stopper puncture. It was clear that someone had withdrawn the controlled-substance contents with a very fine needle and refilled the vial with junk. Whew."

Demerged

"Like many pharmaceutical companies, mine was planning for a merger," said our stressed-out GMP Agent-In-Place. "Rumors ran rampant through the company about layoffs, site closings, and management changes. I happened to be at an industry conference during the Federal Trade Commission review [for the merger] and met a few of my future colleagues. In retrospect, I acted too much like a senior dufus know-it-all, especially after FTC nixed the deal."

No help here

"I had just taken over the scheduling department at our facility after a minor shuffling of staff," our newly promoted GMP Agent-In-Place noted. "One key responsibility involved oversight of a new employee in our contract manufacturing area who had no experience.

"When I asked the person that had previously had my job for help, he demurred, saying 'No one helped me when I took it over, so I won't help you either.' We managed to muddle through the process, but as luck would have it, I didn't last six months in the new position before being laterally transferred."

Toxic data

"A preclinical toxicology animal laboratory generates a lot of data," explained our GMP Agent-In-Place. "I was the first on-site statistician, and no one knew how they had previously analyzed their data. It clearly had been managed poorly. After the first study was completed, the staff took an entire year to read the slides and assemble the data. Then, they gave me less than one week to analyze the data. They had failed to include data analysis as part of their schedule.

"After that experience, I created a standardized computer routine for data analysis. Unfortunately, our mainframe computer at the time only had 32K of memory. That's right, 32K. I provided the algorithms and test data and performed code checks and system tests to handle studies of hundreds of animals with data for many check points. The system checked for non-normality and used the appropriate parametric or nonparametric statistics to find the statistical significance of the changes in the animals. It was a real time-saver," remarked our Agent.

Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the files of Control, a senior compliance officer. If you have a story to share, please email it to Control at
. We won't use any names, but if we do use your experience in the column, you'll receive a Pharmaceutical Technology t-shirt.

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