White Paper

Steps To Ensuring A Successful Audit: Effective Risk Assessment Design

By Gilberto Dalmaso, Ph.D.

Fill Finish Pharmaceutical Manufacturing

When related to Environmental Monitoring (EM), risk management often refers to a complete understanding of how often and how severe a process can be affected by external factors. The development of this knowledge, a risk assessment, is the culmination of multiple party's efforts, including Quality Engineers, Microbiologists, and Production staff. Actions involved in completing a risk assessment start at the very beginning of new cleanroom construction with the identification of product impact sources. The relative risk to product quality is given hierarchy using well-established assessment tools.

In order to prepare for this process, it is important to attain a strong base of EM knowledge.

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