Healthcare Training 2021 - GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Overview:
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.