Avoiding Drug Shortages With Microbial Detection

By Aric Meares, President and CEO, BioVigilant

Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. It takes great vision and courage to drive such a fundamental change in your manufacturing processes, especially in a regulated environment. The driving force for such a change is often driven by quality, but they face natural resistance from their financial organizations who expect a short return on investment and their manufacturing teams who are focused on maintaining the continuity of the processes that allow them to meet quarterly production goals.