Social Distancing Doesn't End At Door: Pandemic Precautions During Onsite Drug GMP Inspections
Executive Summary
“Any practices that limit the social interaction between the investigator and the firm are always good,” says FDA ORA official Rachel Harrington. Donald Ertel, of FDA’s Center for Biologics Evaluation and Research, encourages firms to “try to maintain a one-way flow through the facility” for investigator plant walkthroughs.