Almost nine years ago, the Food and Drug Administration (FDA) held a public meeting to discuss the oversight of laboratory developed tests (LDTs). As LDTs became more complex and integral to clinical diagnostics, the agency considered a risk-based approach for…
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Pharmaceutical microbiologists have the great responsibility of ensuring their products are free of harmful contaminants and safe for consumers. Earlier this month at the Pharmaceutical Microbiology Fall Forum in Philadelphia, Microbiologics Vice President of Research and Development Brian Beck Ph.D….
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Dear Stanley, I’m completely confused about the terms “assayed” and “unassayed” in relation to controls for molecular diagnostic instruments. Does “unassayed” mean the manufacturer of the control hasn’t tested the products? Can you shed some light on what these terms…
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There are many misconceptions in the clinical industry regarding laboratory quality control materials. With numerous products available and manufacturers using various labeling practices, how do you know what’s best for your laboratory? To help clear up the confusion, we’re answering…
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As regulatory standards continue to increase, additional responsibility is being placed on laboratories to ensure the quality and safety of finished products. Now more than ever, traceability is a major concern. Laboratories are required to provide evidence that the reference…
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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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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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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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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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