Glossary
Environmental Monitoring
Continuing checks on the particle and microbial condition of cleanrooms and clean air equipment, at defined locations and frequencies.
Details
Environmental monitoring watches viable and total particles, personnel, and the environmental conditions required, according to a risk assessment, and so demonstrates through trends that clean areas remain in control. Inspections cite sampling plans that do not reflect worst case locations or the time of operation, inappropriate alert and action limits, and inadequate investigation of recurring isolates and excursions, or the omission of a batch impact assessment. Check the CCS and risk assessments, the rationale for locations and frequencies, incubation and identification data, personnel monitoring, trend reports, and deviations and CAPA.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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As it relates to your environmental monitoring (EM) program, your response refers to numerous procedures and corrective and preventative actions (CAPAs) that were either updated or will be revised to address the concerns identified, but deficiencies remain.
FDA · FDA Warning Letter · 2025-11-25 -
Specifically, your firm did not have an environmental monitoring program, did not perform any microbiological testing of facilities or equipment, and did not have established cleaning procedures or records.
FDA · FDA Warning Letter · 2023-05-09 -
Your firm failed to perform adequate routine environmental monitoring.
FDA · FDA Warning Letter · 2025-04-29
