July 30, 2024
Enroll in the Environmental Monitoring in Compounding Course
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Download Slides & Transcript (Compounding)
Presentations
Question & Answer Session (Compounding)
About This Course
Attendees 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.
Intended Audience
- Outsourcing facilities
- Compounding pharmacies
- State pharmacy regulators
- Consultants who work with outsourcing facilities and compounding pharmacies
Topics Covered
- What is environmental monitoring and why is it important in compounding quality and patient safety?
- How environmental monitoring is used to assess the dynamic conditions of the production area and identify potential routes of contamination
- Statutory requirements for compounding pharmacies (503A) and outsourcing facilities (503B)
- Regulatory requirements and the agency’s expectations
- Techniques and methods specific to environmental monitoring
- Key concepts related to design and implementation of environmental and personnel monitoring programs
Learning Objectives
- Define environmental monitoring and its significance in ensuring product quality and patient safety
- Describe statutory requirements for compounding pharmacies (503A) and outsourcing facilities (503B)
- Explain regulatory requirements and the agency’s expectations
- Identify types of monitoring specific to environmental monitoring
- Recognize concepts related to design and implementation of environmental and personnel monitoring programs
Resources
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry | FDA
- Insanitary Conditions at Compounding Facilities | Guidance for Industry | FDA
- Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice | Guidance for Industry | FDA
- Microbiological Quality Considerations in Non-Sterile Drug Manufacturing | Draft Guidance for Industry | FDA
- Human Drug Compounding | FDA
- Compounding Quality Center of Excellence | FDA