The goal of conducting an environmental monitoring risk assessment is to gather information to determine how best to allocate monitoring resources to ensure processes are operating under control.

These guidelines provide step-by-step instructions for the environmental monitoring risk assessment process and recommend monitoring sites and methods based on the likelihood of contamination. The industry guidelines aim to capture best practices in a user-friendly toolkit format.

The guide incorporates best practices from #biopharmaceutical #manufacturers and complies with current #regulatory directives.

From this toolkit you can learn:
What are the risk factors to consider?
How can we systematically evaluate a classified area presenting these risk factors?
How to define risk levels?
What are the minimum standards for monitoring classified areas of different cleanroom levels?

Adoption by regulators and industry will lead to consistent application of best practices and informed discussions with regulators.

#biopharma #toolkit #environmentalmonitoring #BioPhorum #FillFinish

Chapters:
0:00 Introduction to the Environmental Monitoring Toolkit
0:25 What is the toolbox? How is this used?
0:51 How was the toolkit created?

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