WG-CC048: Guidance of design, performance, and operations for controlled environments per usp 797

This Recommended Practice (RP) provides guidance for the design, performance, and facility operations of pharmaceutical sterile compounding controlled environments in accordance with USP 797 ”Pharmaceutical Compounding – Sterile Preparations.” This RP is intended for designers, facility directors, operators, qualified/accredited contractors, and quality assurance of pharmaceutical compounding controlled environments.

This Recommended Practice is being developed by Working Group 48 of the IEST Contamination Control Division (WG-CC048).