Mice on a Mission - Pharmaceutical Technology

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PharmTech Europe

Mice on a Mission
To ensure the accuracy of scientific testing, protect the subjects to avoid data contamination.


Pharmaceutical Technology
Volume 36, Issue 12

Party animals

"My first job out of college was at a pharmaceutical toxicology animal facility," our GMP Agent-In-Place reminisced. "The purebred white mice under study were kept, separated by sexes, in the standard plastic tray cages. A few months into the study, some mice were pregnant, and the babies were brownish. This indicated that the male was a wild animal that somehow got into and out of the cages. We wondered if it was still wandering around in our facility," our Agent laughed. "We had to discard the data from those particular cages to be sure the pregnancies weren't affecting our results."

Sterile or not?

"We performed product bulk-sterility tests by sampling the product through the filling tubing," explained our GMP Agent-In-Place. "When we had several failing bulk-sterility tests in a row, we were worried. Our investigation uncovered that the failures were artifacts caused by sampling and sample handling errors, but such errors are nearly impossible to prove. Our main evidence showed that repeated tests passed in each case. This was not a patient safety issue as we sterile-filtered the bulks for a second time before filling as allowed by our license. However, there was a problem with the process for taking sterile bulk samples if the process is causing failures. We identified aseptic sampling ports that could be added to the sterile bulk vessels at a cost of $8000 each to correct the failure. With 12 vessels, however, the cost was more than we had available in the budget for the fiscal year, and no one wanted to approach headquarters for the money. We did add the sampling ports the next fiscal year."

Calculating inspector

"We use alcohol in our manufacturing process," stated our GMP Agent-In-Place. "So the local Bureau of Alcohol, Tobacco, and Firearms inspector came to visit to verify our submissions as to usage. In our records we calculated purchasing, storage, and usage in liters. However, all of the inspector's formulas were in gallons and he needed a conversion. Even though I explained how it was done, he seemed to not be able to manage the conversion. I did the calculations for him, and gave him a complete, detailed sheet showing the numbers, the formulas, and the conversion factors used. Then he sat down at an empty desk, opening his briefcase and pulled out a tape dispenser, a stapler, and wrote out the entire report by hand."

Rotating employees

"I was asked to help interview new staff by a colleague in the global quality department," began our GMP Agent-In-Place. "He wanted a second opinion to assist with the evaluation process, and thought my 30 years in the industry would help him. When we sat down at the end of one particular interview, I voiced concern that the candidate changed jobs every two years, and this wouldn't allow him to be very effective for us as it takes six months or more to learn a new company and their processes. My colleague was indignant, stating that was his resume pattern as well."

"I had to laugh to myself," our Agent went on. "When I helped interview him for his position, that was my concern then as well. It turned out he left the company after only three years. I don't need to change jobs every two years. On average, I've had a new boss every two years within the same company."

Thank you

This is my last column. I have enjoyed the opportunity to write and hope you have found Agent-In-Place both entertaining and educational. Thank you.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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