Pharmaceutical Cleanroom Environmental Monitoring Checklist
Cleanroom environmental monitoring programs protect product sterility and quality. This checklist verifies all EU GMP Annex 1 and FDA guidance environmental monitoring requirements for pharmaceutical cleanroom operations.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Daily (Critical Areas) / Weekly (Supporting Areas)
- Estimated Time: 20-30 minutes
- Role: QA Officer / Microbiologist
- Total Items: 31
- Compliance: EU GMP Annex 1 (2022) - Manufacture of Sterile Medicinal Products, FDA Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing (2004), ISO 14644-1 - Classification of Air Cleanliness, USP <1116> Microbiological Examination of Nonsterile Products
Non-Viable Particle Monitoring
Verify non-viable particle monitoring.
- Particle counter calibrated and within certification date?
- Particle sampling performed at all required monitoring locations per SOP?
- Grade A non-viable particle counts within EU GMP Annex 1 limits?
- Grade B non-viable particle counts within limits?
- Particle monitoring data recorded in environmental monitoring log?
Viable Environmental Monitoring
Verify viable monitoring samples.
- Settle plates exposed at required locations for correct exposure time?
- Active air samples collected with calibrated RCS or similar device?
- Contact plates and swabs collected from critical surfaces?
- Personnel gown sampling (gloves, gown) performed per program?
- All viable samples submitted to microbiology lab with chain of custody?
Physical Parameter Monitoring
Verify temperature, humidity, and pressure.
- All room pressure differentials within required limits (typically 10-15 Pa between grades)?
- Room temperatures within validated limits?
- Relative humidity within validated limits (typically 30-65% RH)?
- All HVAC systems operating with no alarms or shutdowns?
- Air change rates verified by recent HVAC qualification?
Gowning and Personnel Controls
Verify gowning compliance.
- All personnel following approved gowning procedure?
- All personnel gown-qualified with current gowning qualification records?
- No exposed skin observed in Grade B or A areas?
- No personnel with illness, open wounds, or skin conditions in cleanroom?
- Personnel behavior compliant - no unnecessary movements, talking, or touching?
Alert and Action Limit Trending
Review EM trending for exceedances.
- No action level exceedances in current monitoring period?
- Alert level exceedances investigated and trend documented?
- EM trending reviewed for adverse trends requiring proactive action?
- Any contamination events investigated with root cause and CAPA?
- Monthly EM summary report prepared and reviewed by QA?
Documentation
Verify EM documentation.
- Environmental monitoring log current for all sampling?
- Incubation temperature records for EM plates on file?
- Organism identification performed for recovered isolates per program?
- Annual EM program review completed to verify alert and action limits remain appropriate?
- EM records retained per site document retention schedule?
- Daily/weekly EM monitoring report completed and filed?
Related Pharmaceutical Life Sciences Checklists
- Pharmaceutical Daily Manufacturing Area Inspection Checklist
- Sterile Manufacturing Area Audit Checklist
- Batch Production Record Review Checklist
- Pharmaceutical Cross-Contamination Prevention Audit Checklist
- Pharmaceutical Product Recall Readiness Checklist
- Active Pharmaceutical Ingredient (API) Manufacturing Inspection Checklist
- Pharmaceutical Equipment Calibration and Validation Inspection Checklist
- Pharmaceutical CAPA Review and Effectiveness Check Checklist
Related Gmp Manufacturing Checklists
- Pharmaceutical Daily Manufacturing Area Inspection Checklist - FREE Download
- Sterile Manufacturing Area Audit Checklist - FREE Download
- Batch Production Record Review Checklist - FREE Download
- Pharmaceutical Cross-Contamination Prevention Audit Checklist - FREE Download
- Active Pharmaceutical Ingredient (API) Manufacturing Inspection Checklist - FREE Download
- Pharmaceutical Equipment Calibration and Validation Inspection Checklist - FREE Download
- Pharmaceutical Daily Manufacturing Area Inspection Checklist - FREE Download
- Active Pharmaceutical Ingredient (API) Manufacturing Inspection Checklist - FREE Download
Why Use This Pharmaceutical Cleanroom Environmental Monitoring Checklist?
This pharmaceutical cleanroom environmental monitoring checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa officer / microbiologist professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: daily (critical areas) / weekly (supporting areas).
Ensures compliance with EU GMP Annex 1 (2022) - Manufacture of Sterile Medicinal Products, FDA Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing (2004), ISO 14644-1 - Classification of Air Cleanliness, USP <1116> Microbiological Examination of Nonsterile Products. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Cleanroom Environmental Monitoring Checklist cover?
This checklist covers 31 inspection items across 6 sections: Non-Viable Particle Monitoring, Viable Environmental Monitoring, Physical Parameter Monitoring, Gowning and Personnel Controls, Alert and Action Limit Trending, Documentation. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed daily (critical areas) / weekly (supporting areas). Each completion takes approximately 20-30 minutes.
Who should use this Pharmaceutical Cleanroom Environmental Monitoring Checklist?
This checklist is designed for QA Officer / Microbiologist professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.