Back to: Environmental Monitoring in Compounding
🔔 Note: Stop playback at 57:11 to complete this lesson.
Presenters
Brandon Heitmeier, MPH, CPH, CPGP
Commander (CDR)
Consumer Safety Officer
Division of Compounding I
Office of Compounding Quality and Compliance (OCQC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Doan-Trang Vuong, MS
Consumer Safety Officer
Division of Compounding I
Office of Compounding Quality and Compliance (OCQC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
This webinar provides a comprehensive overview of environmental monitoring (EM) for compounding facilities, encompassing its definition, statutory, and regulatory requirements for both 503A and 503B facilities. EM involves conducting various tests, such as sampling the air and surfaces, performing assays, and taking measurements of environmental conditions like temperature, differential pressure, and humidity. It serves as a vital quality metric, offering insights beyond visual cleanliness, helping to assess the adequacy of cleaning procedures, the effectiveness of disinfection agents, and the performance of HVAC systems. Combined with personnel monitoring (PM), EM also reveals insights into staff hygiene and potential contamination sources, as humans are a primary source of contamination in cleanrooms. While EM is not a release test and has inherent limitations regarding precision and representativeness, it is a crucial expectation under both insanitary conditions and Current Good Manufacturing Practices (CGMPs). An adequate EM program is essential for aseptically produced drugs to ensure compliance, with the frequency and type of monitoring varying based on the production type and associated risks, typically being more rigorous for 503B outsourcing facilities. Identifying and investigating adverse trends in EM data is critical for maintaining a controlled production environment and initiating corrective actions.