Weathering The Storm Of Regulatory Compliance In Aseptic Manufacturing

By Alex Mello, Microtest

When the U.S. Food and Drug Administration (FDA) conducts an unscheduled inspection of your aseptic manufacturing process, it can hit with the fury of a New England nor’easter. But just as careful planning and forecasting help us safely ride out the storm, a best-practice control and monitoring system minimizes the danger of FDA noncompliance.

Governments hold aseptic fill/finish manufacturers to the highest standards and regulations. Rightly so, since parenteral products are highly vulnerable to contamination as they journey from the production suite to the shipping dock to the clinic or pharmacy. Any deviation from the tried-and-true methods of aseptic filling can have a deleterious effect on product safety. However, sometimes we become so focused on regulatory requirements that we overlook the best scientific approach to compliance.