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What is Handling of Out of Specification Result in Pharmaceutical Lab. about?

The document outlines the definitions and procedures related to Out-of-Specification (OOS) and Out of Trend (OOT) results in laboratory investigations. It details the investigation phases, responsibilities of analysts and supervisors, and the process for retesting and resampling. Additionally, it includes statistical methods for identifying outliers, specifically the Dixon

Author

Zafar

Language

EN