N. 87 - Useful information about Pharmaceutical Environmental Microbiology

How do you set Alert and Action Levels in Environmemtal Microbiology? Most companies have chosen a harmonized approach using the recommendations from the EU and the FDA, to include applying the most stringent criteria where applicable, although some companies stated that they use the most stringent criteria across the board. However, the regulators prefer to see Alert and Action Levels based on historical data once the EM program has been established for a minimum of 12 months.