New CDC report, old lesson: Sterility in manufacturing is crucial

The TV show “Monk” may turn obsessive cleanliness into comedy, but for drug and device manufacturers, the importance of sterility cannot be taken lightly. The tiniest, most microscopic contamination can have far-reaching, devastating effects, not only for patients but for every employee in your company if it leads to dire enough circumstances. Fortunately, we have a system that includes the FDA’s good manufacturing practices to prevent contamination and other problems. Still, every now and then we get a reminder of how important it is that we keep a vigilant watch over our manufacturing processes.

We have just had such a reminder. The Archives of Internal Medicine last month published a report by Centers for Disease Control and Prevention investigators that a bloodstream infection outbreak that encompassed nine states from October 2007 to February 2008 was likely the result of one (unnamed) company’s contaminated pre-filled syringes of heparin and saline.

Further, the report said CDC personnel found a lack of safety-regulation compliance on the part of the company. "An onsite inspection of the manufacturer by the FDA revealed poor compliance with the FDA's GMPs and quality-system regulations. Within days of this inspection, company X discontinued production of all medical products," as well as recalled existing products, the report authors wrote.

Our regulators are here for a reason. Your average Joe may simply think regulators are here to protect consumers, but of course you can’t protect consumers without protecting us, too. Through regulations and inspections we are reassured that we are taking all the necessary steps to make safe, effective products that can claim their share of the marketplace. We are also protected from unscrupulous manufacturers who would otherwise take dangerous shortcuts and tarnish the industry’s reputation for everyone.

Needless to say, the ramifications of not following GMPs and other relevant regulations can be life-altering. But as we know, the majority of the industry doesn’t have to be reminded of that, as noted in an editorial from former FDA associate commissioner William K. Hubbard that accompanied the report. He wrote: “Drugs made in the United States under the FDA’s rigorous quality-control standards have an extraordinarily good safety record, as measured by the paucity of manufacturing defects and deaths and illnesses related to manufacturing deficiencies.”

Anyone interested in brushing up on regulations can take a look here, a comprehensive source on the FDA Web site. I invite you to submit comments on this or other manufacturing issues at commentary@INTERPHEX365.com.