USP Chapter 797 refers to which topic?

USP Chapter 797 refers to which topic?

• A. Pharmacovigilance
• B. Quality control of excipients
• C. Sterile compounding
• D. Over-the-counter labeling

Answer: (C)

Sterile compounding. USP Chapter 797 sets the standards for preparing sterile drug products, focusing on the environment, personnel practices, and quality controls needed to prevent contamination and ensure product safety. It covers facility design and engineering controls (like cleanrooms and appropriate air quality), garbing and aseptic technique, equipment and sterilization validation, handling of ingredients, cleaning and disinfection, environmental monitoring, beyond-use dating, labeling, storage, and a formal quality assurance program with staff training. The other topics listed—pharmacovigilance, quality control of excipients, and OTC labeling—are not what Chapter 797 addresses; they fall under different regulatory or quality areas.

Sterile compounding. USP Chapter 797 sets the standards for preparing sterile drug products, focusing on the environment, personnel practices, and quality controls needed to prevent contamination and ensure product safety. It covers facility design and engineering controls (like cleanrooms and appropriate air quality), garbing and aseptic technique, equipment and sterilization validation, handling of ingredients, cleaning and disinfection, environmental monitoring, beyond-use dating, labeling, storage, and a formal quality assurance program with staff training. The other topics listed—pharmacovigilance, quality control of excipients, and OTC labeling—are not what Chapter 797 addresses; they fall under different regulatory or quality areas.