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← All virtual labs

Reviewing Environmental Monitoring Results

Sort a day's EM results into within limits, alert and action, choose the actions and spot a developing trend.

What you will practise

Evaluate EM results against Annex 1 limits and site alert levels, and respond proportionately.

Annex 1 Table 6 limits
Alert versus action
Excursion response
Trending

Based on

EU GMP Annex 1 (2022), Table 6
USP <1116>
PDA Technical Report 13

Every attempt uses new data. You need 70 % to pass. Explanations appear after each step.

About 10 minutes

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