Articles by Jeffrey Hartman - Pharmaceutical Technology

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Articles by Jeffrey Hartman

Jeffrey Hartman


Jeffrey Hartman is a validation manager in regulatory and analytical sciences with Merck & Co., Inc.

Risk-Management Assessment of Visible-Residue Limits in Cleaning Validation
September 2, 2006

Before formal cleaning validation programs were instituted, visual inspection was the primary means of determining equipment cleanliness. The use of visual inspection is still typically a component of a cleaning validation program and for routine inspections of cleaning effectiveness, but the use of visual inspection as a sole criterion for equipment cleanliness has not been successfully implemented as a valid approach for cleaning validation.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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