Establishing a PHARMA Environmental Monitoring Program

"In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. The EM 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 corrective actions before product contamination occurs.

Jan 1, 2019