Tag Archive: FDA

Non-Sterile Pharmaceuticals: Next Steps After Finding an Environmental Isolate

You’ve identified an organism in your environment. Now what? If you work in a non-sterile pharmaceutical manufacturing laboratory, chances are you’ve encountered this question. You know environmental monitoring doesn’t stop at detection, but what are the correct next steps to…
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The Scoop on Ready-to-Eat Foods and Listeria monocytogenes

When summer is in full swing, many of us choose to cool down with sweet frozen dairy treats. However, the thought of ice cream tainted with Listeria monocytogenes may cause anyone, especially those in susceptible populations, to think twice. Listeria…
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The Great Debate Over B. cepacia Testing: Your Opinions and FDA Recommendations

Last month we outlined the debate for and against requiring B. cepacia testing for all nonsterile pharmaceutical, personal care products and water systems (The Great Debate Over B. cepacia Testing). At the end of the post, we asked our readers…
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Objectionable Microorganisms: Keeping Bad Bugs Out of Good Products

No pharmaceutical company wants to sell a non-sterile drug contaminated with objectionable microorganisms, but how does a company know which organisms are objectionable and how do they ensure their drugs do not contain them? An objectionable organism is one which…
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