FDA Regulations -2017 on GMP Environmental Monitoring -Maintaining a Clean Room
Instructor : Roger Cowan
Oct 31, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes
Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring.
This webinar first explains the various US and international regulatory requirements for the various clean room classifications as well as the environmental monitoring of clean room environments. Next, the presentation details the benefits, the regulatory requirements and the testing requirements for a comprehensive Environmental Monitoring Program.
A description of Action and Alert Levels follows along with a discussion of how these levels are determined for a particular facility. Corrective and Preventative Actions are defined. All current air monitoring systems for the measurement of non-viable particulate are fully reviewed. All current air and surface monitoring systems for the measurement of microbial contaminants in the clean room are discussed in detail.
The subject of clean room contamination due to personnel is discussed. This includes both gowning technique and aseptic practices. Ongoing monitoring practices for the clean room environment are discussed with respect to sampling frequency, sampling locations, and the investigation of action level excursions. This is followed by a discussion of how environmental monitoring data is reviewed for product release.
Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room.
As the FDA Guideline on Aseptic Processing GMP (2004) states:
“In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs".Therefore, ongoing environmental monitoring of a clean room environment is necessary to assure the quality and safety of the pharmaceutical product.
Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.
- GMP Compliance of Clean Room Environment
- Regulatory Clean Room Classification and Requirements
- Environmental Monitoring Program
- Action and Alert Levels
- Non-Viable Particulate Monitoring Systems
- Microbial Monitoring Systems
- Personnel Gowning and Aseptic Practices in Clean Room
- Clean Room Monitoring Practices - Frequency, Locations, and Investigations
- Product Release
- Environmental Monitoring Data Trend reports
This webinar will provide valuable assistance to all personnel in:
- Quality Assurance
- Environmental Monitoring