An Introduction To Trending In Environmental Monitoring Programs
Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if a facility is in a state of microbial control and relay the environmental monitoring data to facility management in a meaningful format. In this two-part article exploring environmental monitoring trending, I look first at the regulations and guidelines around EM. In part two, I will discuss tools and best practices for using the trends to ensure that an efficient environmental monitoring program is established.
EM is a required, essential component of current good manufacturing practices (cGMP). It is used to measure and monitor the microbial bioburden levels in a facility and to determine if the facility is in a state of microbial control. EM consists of many different data points that culminate in a single program. Some of the data point