By Anna Campanella, Ph.D., Global Pharma GMP Advisor, Particle Measuring Systems
Routine review and analysis of environmental monitoring data for trends at an appropriate frequency is essential to aid in the interpretation of process stability and assess overall environmental control performance.
Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. It’s possible to use the limits reported in FDA guidelines or Annex 1 of Eudralex – Volume 4 when the facility is new and/or there is not available data. When there is statistically significant data, it’s essential to establish the proper alert and action limits.