Meaningful Metrics for the Microbiology Laboratory
Posted on June 2, 2014
By: Karen Zink McCullough, Principal Consultant
MMI Associates
Background In a February, 2013 Federal Register notice, the United States Food and Drug Administration (FDA) described a plan for the mitigation of drug shortages, and asked for public comment on that plan1. As part of that initiative, the Agency proposed the following: II.1.a, “To assist in the e...
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Related Topics and Keywords
Batch Failure Rate, Confirmed OOS/Laboratory failure investigation rate, endotoxin, FDA, formulation, Karen Zink McCullough, Meaningful quality metrics, Metrics, microbiology, MMI Associates, Nonsterile dosage form, Out of Specification Results (OOS), Right First Time, vaccine
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