On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective ...
Environmental monitoring requirements in ATMP facilities, addressing regulatory compliance, GMP standards, and contamination ...
Explore key questions on contamination control strategies to support regulatory compliance and risk management in ...
As Advanced Therapeutic Medicinal Products (ATMPs) surge in popularity and the market sees an increase in therapy development and available products, contemporary manufacturing processes must align ...