QMS SOP Template: Environmental Monitoring Excursions

Published: July 2025
Pages: 12

• Special Pricing for Emerging Economies

Effective management of Environmental Monitoring (EM) excursions supports contamination control strategies and promotes continual improvement in the pharmaceutical quality system.

This Standard Operating Procedure (SOP) template defines the process for identifying, documenting, investigating, and addressing EM excursions within pharmaceutical manufacturing and cleanroom environments. An EM excursion refers to any result that falls outside of established microbiological or physical control limits, potentially impacting product quality or aseptic conditions. This SOP helps the user to ensure that all such deviations are handled in a timely manner, in accordance with applicable regulatory guidelines such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and European Union (EU) Good Manufacturing Practice (GMP) Annex 1 through timely investigation, risk assessment, and resolution while linking directly to the corrective action and preventive action (CAPA) system to facilitate root cause analysis, implementation of corrective measures, and monitoring of recurrence trends.