A Complete Guide to Environmental Monitoring
This module provides an in-depth review of the regulatory requirements of environmental monitoring (EM) of cleanrooms, parameters to be monitored and the tools and techniques used for environmental monitoring.
Fundamentals of cleanrooms
Which activities are covered under Environmental monitoring
Regulatory expectations related EM
Parameters to be monitored in cleanrooms
Viable particle monitoring
Passive, active, surface and personnel monitoring
Components of ideal EM program
Alert and action limits
UPS 1116 and Contamination recovery rates
Why it matters
Environmental monitoring is one of the key aspects affecting product quality in the manufacture of sterile medicinal products. Both EMA and USFDA GMP regulations place special focus on this topic. Gaps in EM procedures and implementation can seriously impact patient safety and attract regulatory action.
Who is it for
This course is aimed at personnel in production and quality functions who wish to increase their understanding of regulatory requirements and expectations for the environmental monitoring of pharmaceutical operations. It will be of particular use to anyone performing environmental monitoring and those involved in collating and interpreting the results obtained during EM.