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生命科学 eQMS 13 项

Out-of-Trend (OOT) Result Evaluation Checklist

此检查清单为英文版。

Provides a structured approach to identify, evaluate, and respond to out-of-trend analytical or stability results that remain within specification but deviate from expected behavior. Use when defining or applying an OOT procedure.

21 CFR 211.192FDA OOS Guidance 2006ICH Q1E

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OOT Definition and Detection

  • Is a documented procedure defining out-of-trend results and detection criteria in place? *
  • Are statistical methods (e.g., regression control limits, by-time-point, slope analysis) defined for trend detection? *
  • Are OOT criteria distinct from out-of-specification criteria? *
  • Are historical data sets adequate to establish expected trends and limits? *

Stability and Trend Types

  • Are OOT evaluations applied to stability data across time points and batches? *
  • Are analytical OOT results (e.g., in-process, release) also captured by the procedure?
  • Is the type of OOT (analytical, process control, or stability) classified for the response? *

Investigation

  • Is a laboratory investigation performed to rule out assignable analytical causes for an OOT? *
  • Is a manufacturing or product-impact investigation triggered when no lab cause is found? *
  • Is the impact on shelf life, other batches, and product on the market assessed? *

Disposition and Trending

  • Is the disposition of the affected batch documented with quality unit approval? *
  • Are OOT occurrences trended over time to detect emerging process drift? *
  • Are OOT findings fed into the annual product quality review?

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