Complying with CGMPs for Sterile Manufacturing.

HEALTH services administration; PATIENT safety; ENVIRONMENTAL monitoring; MICROBIAL contamination; QUALITY control; PHARMACEUTICAL industry; STERILIZATION (Disinfection); REGULATORY approval

The article focuses on compliance with current good manufacturing practices (CGMPs) in aseptic sterile manufacturing for contract pharmaceutical companies. Topics include the importance of media fills and smoke studies for contamination control, the role of environmental and particulate monitoring, and the necessity of strict cleaning and disinfecting processes to ensure product quality and patient safety.