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Life-Sciences eQMS 19 items

Environmental Monitoring Program Checklist (Viable & Non-Viable)

Evaluates the design and execution of a cleanroom environmental monitoring program covering viable and non-viable particulate, surface, and personnel monitoring. Use for EM program review and audit.

EU GMP Annex 1ISO 14644USP <1116>FDA Aseptic Processing Guidance 2004

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Program Design and Risk Basis

  • Is the EM program based on a documented risk assessment of contamination sources and process activities? *
  • Are monitoring locations justified and mapped for each cleanroom grade? *
  • Are alert and action levels established for each location and grade? *
  • Are sampling frequencies defined for at-rest and in-operation states? *

Non-Viable Particulate Monitoring

  • Is total airborne particle monitoring performed against the classification limits for the grade? *
  • Is continuous particle monitoring in place for Grade A during critical operations? *
  • Are particle counters calibrated and qualified? *
  • Record the classification grade being monitored.

Viable Monitoring

  • Are active air, settle plate, and surface (contact/swab) monitoring performed at defined locations? *
  • Is personnel monitoring (gloves and gown) performed for aseptic operations? *
  • Is media growth promotion tested and incubation conditions defined for recovery of relevant organisms? *
  • Are recovered microorganisms identified to an appropriate level, especially in Grade A/B? *

Excursion Management

  • Are alert and action level excursions investigated per procedure? *
  • Is product impact assessed for excursions during production? *
  • Are adverse trends and objectionable organisms escalated? *

Data Trending and Review

  • Are EM data trended over time to detect shifts and drifts? *
  • Is periodic review of alert/action levels performed based on accumulated data? *
  • Is the contamination recovery rate assessed against expectations for each grade? *
  • Is a periodic EM summary reviewed by the quality unit? *

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