- 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
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.”
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 36 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.
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