Tag Archive: FDA

Dear Stanley: Assayed vs Unassayed Molecular Controls

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…
Read more

Research Use Only or IVD: What’s Right for Your Lab?

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…
Read more

How Certified Reference Materials Help Labs Meet Regulatory Requirements

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…
Read more

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…
Read more

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…
Read more

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…
Read more

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…
Read more