Environmental Monitoring in Compounding

Viewers will hear an overview of Environmental Monitoring for compounding facilities and the role environmental monitoring plays in ensuring product quality and patient safety. Presenters will discuss the statutory and regulatory requirements for environmental monitoring. FDA also will describe the agency’s expectations for compounding pharmacies (under section 503A) and outsourcing facilities (under section 503B) for environmental monitoring. Finally, FDA will discuss different methods specific to environmental monitoring.
Timestamps
00:45 - Introduction
03:22 - What is Environmental Monitoring
09:31 - Statutory Requirements
17:26 - Regulatory Requirements and Expectations
21:06 - Types of Monitoring
34:39 - Environmental Monitoring: Viable Particles
36:31 - Limitations of sterility Testing
37:40 - Microbial Testing
41:24 - Methods Used to Monitor Viable Particle in Air
45:47 - Personnel Monitoring
56:00 - Environmental Monitoring Summary
01:00:00 - Q&A Session
Speakers | Panelists:
CDR Brandon C. Heitmeier, MPH, CPH, CPGP
Consumer Safety Officer
Division of Compounding I
OCQC | OC | CDER | 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) | FDA
Learn more at: www.fda.gov/dr...
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