Audit - 13

Audit Manual 13 - Auditing Environmental Monitoring System

Perform an Environmental Monitoring Audit. Use a range of tools and information, including the contents of this unit and the Intranet, to support an Environmental Monitoring Audit. Apply worldwide regulatory agency requirements to Environmental Monitoring.

Audit 13 - Auditing Environmental Monitoring System

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An environmental monitoring program provides information on the non-viable particulate and microbiological quality of the environment being monitored. Such data provides an insight into the effectiveness of the control programs (e.g. cleaning, housekeeping, gowning, air handling) that are in place. Controlled environments must be monitored using the appropriate regulatory guideline and industry practices. Areas defined as controlled environments must be monitored as appropriate for that environment. Monitoring programs must be based on the processing requirements of the area and the risk assessment of the area.

In non-classified areas, a level of microbiological monitoring is necessary as part of an ongoing risk assessment to maintain awareness of the microbiological environmental conditions during manufacturing activities.

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