Article Archives

Drug Pedigrees: Your Supply Chain Needs Them. Are You Ready?

This article describes the challenges of drug counterfeiting and the consequences when companies fail to recognize the threat. It then outlines the technical solutions that are available, assesses the merits of those solutions, and shows which solution fits best in different situations. Read it here.

New Dietary Supplement Regulations: What You Need to Know

In 2007 the Food and Drug Administration has published new Current Good Manufacturing Practices (CGMPs) regulations for dietary supplements. These regulations affect any manufacturers of dietary supplements who sell product in the United States.

The Evolution of Process Validation

In November 2008, the U.S. Food and Drug Administration (FDA) published draft guidance on process validation. Entitled Process Validation: General Principles and Practices, this draft guidance replaces the previous guidance issued in 1987.

FDA's New Warning Letter Practices

Industry has been waiting to see how Dr. Hamburg's new Warning Letter policy will be implemented. We found out more at MichBio Expo 2010. Steven Barber, Director of the Compliance Branch at the Detroit District Office said that the District must explain why the product was not seized if a Warning Letter is warranted.

FDA's New Process Validation Guidance Recommends Team Approach

The November 2008 FDA draft guidance for process validation says "We recommend an integrated team approach to process validation that includes expertise from a variety of disciplines..." But when different people from different backgrounds work together, disagreements can stall your team. How do you get your project back on track?

Five Ways to Accelerate Root Cause Investigations

Finding the root cause for errors and preventing them from happening again is always good business. Your quality improves every time you prevent an error. Costs go down. And in some industries, like pharmaceuticals or medical devices, it's more than good business. It's the law. So there are plenty of incentives to find the root causes for errors.

Food Recalls and Mislabeling: How to Avoid Mistakes Before Products Hit the Shelves

Spring is often a time that allergy sufferers dread. But for those who are allergic to food ingredients, that dread can be a daily occurrence. Following ingestion of a food allergen, a person with food allergies can experience anaphylaxis, which can lead to constricted airways in the lungs; severe lowering of blood pressure and shock ("anaphylactic shock"); and suffocation by swelling of the throat.

How to Get Your Project Approved

What do you do when you have a great idea? You know how to save your company a ton of money or you've thought of a way to really improve a product. The problem is that you know that you have a great idea, but no-one else does. And you can't convert this idea into reality by yourself. You need resources. You need money. You feel that you need permission. What do you do?

Labeling Errors Make Recalls Likely

The Food and Drug Administration (FDA) regularly monitors labels for false claims and errors, often pulling whole lots of product for which it finds a problem. Case in point: a recent nationwide recall of Encore Tablets, a dietary supplement sold in health food stores, via the internet and by mail order nationwide and in Canada.

The Myth of the Generic SOP

What do you do when your boss tells you to write an SOP? Run and hide? Tell her how long it will really take to write one that’s any good? If you choose the latter option, be prepared for this “helpful suggestion”: “Why don’t you just download a generic SOP from the internet?” You would have been better off taking the former option. Here’s why.

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