The Strategic Role of Microbiology Quality Control

Microbiology quality control testing in sterile and non-sterile manufacturing can often be perceived as a laborious, tactical part of the overall manufacturing of products.  Recently, though, microbiology-related events have shown the critical importance of this testing. 

A North Carolina pharmaceutical plant will be resuming operations after “routine tests” uncovered bacteria that cause Legionnaires ’ disease in their cooling towers.  This comes only a few weeks following news that the NIH has suspended drug production for 46 clinical trials after finding fungus contamination in two product vials.  

These recent, high-profile events serve as a reminder of the strategic role of microbial quality control testing.  In these instances, the discovery of contamination lead to a plant or manufacturing shutdown, having a significant impact not only on the facility, but on the business as a whole. 

While it is easy to get lost in the day to day tactical aspects of quality control testing in the lab, the testing being done provides a considerable benefit to manufacturing and the organization. By uncovering potential contamination quickly, the lab allows the business to respond proactively, protecting customers, patients and the community.

For microbiology the path to a result is time consuming, Microbiologists capture samples, incubate them for a period of time, then read and record results.  If samples are out of specification, the lab performs and investigation and root cause analysis as part of good manufacturing practices.  As a strategic component of the enterprise, the lab must continually search for innovative tools and techniques to enhance their efficiency and optimize the resources associated with these critical tests.