Environmental Monitoring Guide – Non Sterile Facility

Guideline (SOP) for risk based Environmental Monitoring (EM) in Non Sterile drug manufacturing facility. Regulatory standards for non-sterile product manufacture and environmental control have not been consistently established, however, EU…

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Environmental Monitoring (EM) – New Approach Guide

This Guideline applies to routine Environmental Monitoring (EM) activities in classified manufacturing areas for viable and non-viable particulates, aseptic area personnel gown and glove samples, and for utility systems supplying…

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