Environmental
Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a
risk-based approach. The use of sampling data for the identification and
mitigation of risk becomes a critical element in this process. No longer is it
enough to utilize data for reactive excursion reporting. The case study
provided in this white paper highlights the need for automated EM software
systems to analyze large amounts of data and recognize risks before a problem
occurs.
Posted by Tim Sandle
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Pharmaceutical Microbiology Resources