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.