GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the cleanroom.
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 the implementation of corrections before product contamination occurs."

Therefore, ongoing environmental monitoring of a cleanroom environment is necessary to assure the quality and safety of the pharmaceutical product.

Also, a proper understanding and testing of the cleanroom 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 first explains the various US and international regulatory requirements for the various cleanroom classifications as well as the environmental monitoring of cleanroom 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 cleanroom are discussed in detail.

The subject of cleanroom contamination due to personnel is discussed. This includes both gowning techniques and aseptic practices. Ongoing monitoring practices for the cleanroom environment are discussed with respect to the 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. Finally, a comprehensive look is taken at the current thinking about the generation and review of Environmental Monitoring Data Trend Reports.

• Quality Assurance
• Environmental Monitoring
• Microbiology
• Manufacturing
• Validation
• Engineering
• Maintenance

Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 37 years experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada.

Roger's areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.