A Complete Guide to Environmental Monitoring

About the Course

This eLearning module provides a comprehensive overview of environmental monitoring practices essential for maintaining cleanroom and controlled area compliance in pharmaceutical manufacturing. Learners will gain insights into monitoring viable and non-viable particles, surface and personnel monitoring, regulatory expectations, and data interpretation. Designed for quality, production, and microbiology personnel, the course emphasizes the importance of routine monitoring in ensuring product safety and GMP compliance.

Content

A Complete Guide to Environmental Monitoring

• Introduction to EM
  • Training Objectives and EM requirements in Schedule M, Revision Dec. 20223
• Cleanrooms
  • Definition, Industry utilizing cleanrooms, and Usage
  • Why Perform Environmental Monitoring?
  • Importance of a Good EM Program
  • What Environmental Monitoring is NOT
• Environmental monitoring program
  • Environmental monitoring strategy
  • Types of Contamination & Sources
  • Parameters of an EM Program including Area Temperature, Relative Humidity, and Differential Pressure
  • Cleanroom Classification
  • Airborne Particulate Matter
• Viable particle Monitoring
  • Role of Viable Particle Monitoring
  • Microbial Contamination and Monitoring
  • Why Do We Care About Viable Particles
  • Growing Bacteria and Fungi in Petri Dishes
  • Understanding Colony Forming Units
  • Microbial Monitoring Methods as Part of EM Program
  • Surface Monitoring, Airborne microbial sampling, Active Air Sampling, Passive air sampling
  • Personnel Monitoring
  • Viable particle limits
  • Selection of sampling sites
  • Importance of Environmental Isolate Identification
• Good EM Program
  • Components of an ideal EM program
  • Ideal EM Program Attribute
  • Alert and Action Limits
  • EM Trend Analysis
  • Qualification and Validation of Tests
  • Regulatory actions
• Auditing EM Program
  • Data Integrity Violations in EM Programs
  • Indicators of Potential Data Manipulation
  • Key Takeways

Summary and Conclusion: Understanding the role of EM in GMP compliance

Final Evaluation: 3 attempts to achieve 70% in the evaluation.