Insanitary conditions can introduce significant risks to compounded drug quality and patient safety, making their identification and prevention an essential component of sterile compounding operations. This session will explore what constitutes an insanitary condition and examine the regulatory expectations surrounding conditions that may cause compounded drug products to become contaminated or otherwise adulterated. Participants will learn to identify high-risk practices and areas within the compounding environment, including equipment, surfaces, personnel practices, and environmental controls. The session will also discuss practical strategies for preventing and correcting insanitary conditions through effective cleaning and disinfection practices, monitoring, documentation, and corrective and preventive actions.
Define and Identify Hazards: Clearly define insanitary conditions (e.g., contamination, pests, poor environmental control).
Risk Assessment: Identifying high-risk areas, such as equipment surfaces, that are prone to contamination.
