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ROI CalculatorEnvironmental Monitoring (EM) is the controlled program to measure, record, and assess cleanliness conditions in manufacturing areas to ensure they do not compromise product quality or patient safety.
FDA 21 CFR 211.42 and 211.113 require appropriate environmental controls to prevent contamination in drug manufacturing. ISO 14644 defines cleanroom classification and monitoring, while ISO 13485 requires control of the work environment where product quality can be affected.
Why it matters: poor environmental control leads to contamination, batch rejection, and major inspection findings.
