PHARMACEUTICAL FACILITY ENVIRONMENTAL MONITORING CHECKLIST 2026

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--- AIR QUALITY & PARTICULATE MONITORING ---
[ ] Sampling Date
[ ] Sampling Area/Room ID
[ ] Non-Viable Particle Count (0.5μm)
[ ] Non-Viable Particle Count (5.0μm)
[ ] Air Filter (HEPA) Integrity Status (Passed, Failed, Not Tested)
[ ] Sampling Methods Used (Active Air Sampling, Passive Air Sampling, Laser Particle Counter)
[ ] Observations & Anomalies
[ ] Performed By (Technician)

--- MICROBIOLOGICAL MONITORING ---
[ ] Sampling Date
[ ] Sampling Zone/Grade (Grade A, Grade B, Grade C, Grade D)
[ ] Sampling Method Used (Airborne (Active), Settle Plates, Surface Swab/Contact Plate, Personnel Glove Print)
[ ] CFU Count Observed
[ ] Compliance Status (Within Specification, Out of Specification (OOS), Alert Level Exceeded)
[ ] Microbiological Deviation Details
[ ] Microbiology Lab Certificate/Raw Data
[ ] Reviewer Authorization

--- TEMPERATURE & HUMIDITY CONTROL ---
[ ] Monitoring Date
[ ] Cleanroom/Storage Zone ID
[ ] Current Temperature (°C)
[ ] Current Relative Humidity (%)
[ ] Temperature Status (Within Specification, Out of Specification (OOS), Alert Limit Exceeded)
[ ] Deviation Notes & Observations
[ ] Verifier Signature

--- SURFACE & EQUIPMENT SANITIZATION ---
[ ] Sanitization Completion Date
[ ] Sanitization Agent Used (70% Isopropyl Alcohol (IPA), Hydrogen Peroxide, Chlorine-based Disinfectant, Phenolic Compound)
[ ] Surfaces Sanitized (Work Benches/Tabletops, Flooring/Walls, Equipment Outer Surfaces, Aseptic Tools/Instruments)
[ ] Contact Time (Minutes)
[ ] Cleaning Deviation Notes
[ ] Sanitization Log/Certificate Upload
[ ] Sanitization Performed By

--- PERSONNEL & GOWNING COMPLIANCE ---
[ ] Inspection Date
[ ] Cleanroom Grade Observed (Grade A, Grade B, Grade C, Grade D)
[ ] Gowning Integrity Checklist (No visible tears or punctures in gloves/sleeves, Mask and head cover fully covering hair and face, No exposed skin visible below gown line, Sterile gowning procedure followed correctly)
[ ] Number of Personnel Monitored
[ ] Gowning Deviations & Observations
[ ] Auditor Signature

--- PRESSURE DIFFERENTIAL & AIRFLOW PATTERNS ---
[ ] Inspection Date
[ ] Cleanroom Zone/Room ID
[ ] Measured Differential Pressure (Pa)
[ ] Pressure Gradient Status (Within Specification, Out of Specification (OOS))
[ ] Airflow Pattern Observations (Unidirectional Flow Maintained, Turbulence Detected, No Visible Airflow Disruption)
[ ] Deviation Description & Observations
[ ] Inspector Signature

--- EQUIPMENT & INSTRUMENT CALIBRATION ---
[ ] Last Calibration Date
[ ] Next Calibration Due Date
[ ] Instrument ID/Asset Number
[ ] Calibration Status (In Calibration, Out of Calibration, Calibration Expired, Maintenance Required)
[ ] Calibration Deviation (Error Margin)
[ ] Calibration Certificate Upload
[ ] Technician Verification

--- DATA INTEGRITY & DOCUMENTATION ---
[ ] Review Date
[ ] Data Integrity Compliance Status (Compliant, Non-Compliant, Observation Identified)
[ ] Checked Documentation Types (Electronic Audit Trails, Manual Logbooks, Temperature Charts, Cleaning Records)
[ ] Discrepancy & Deviation Notes
[ ] Supporting Evidence/Scan Upload
[ ] Reviewer Authorization

--- CORRECTIVE & PREVENTIVE ACTIONS (CAPA) TRACKING ---
[ ] Date of Environmental Excursion
[ ] Excursion Severity Level (Low (Alert Limit), High (Action Limit), Critical (Out of Specification))
[ ] Deviation Reference Number
[ ] Description of Environmental Deviation
[ ] Root Cause Analysis Summary
[ ] Corrective Actions Implemented (Re-sanitization of Area, Equipment Repair/Maintenance, Personnel Re-training, HVAC System Adjustment)
[ ] CAPA Completion Deadline
[ ] Quality Assurance Approval

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