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Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification
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Understanding the Added Value of Action Limits for QTL Monitoring.

Nathalie van Borrendam1, Annett Keller2, Leon Els3

  • 1Integrated Data Analytics and Reporting, Johnson & Johnson, Graaf Engelbertlaan 75, 4837DS, Breda, Netherlands. nvanborr@its.jnj.com.

Therapeutic Innovation & Regulatory Science
|July 2, 2026
PubMed
Summary

Quality tolerance limits (QTLs) manage trial risks to maintain quality. Action limits provide early risk detection through continuous monitoring, preventing impacts on statistical analyses.

Keywords:
Acceptable rangeAction limitCritical-to-Quality (CtQ) factorEarly detectionQTL parameterQuality Tolerance Limits (QTLs)

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Area of Science:

  • Clinical trial management
  • Pharmaceutical quality control
  • Risk-based quality management

Background:

  • Quality tolerance limits (QTLs) are crucial for managing risks in clinical trials.
  • Ensuring critical quality aspects remain within acceptable ranges is essential for trial integrity.
  • Continuous, real-time data monitoring is vital for proactive risk management.

Purpose of the Study:

  • To explain the role of action limits in early risk detection within clinical trials.
  • To illustrate the characteristics of QTL parameters, thresholds, and action limits.
  • To provide practical examples for understanding QTL implementation.

Main Methods:

  • Defining Quality Tolerance Limits (QTLs) and their parameters.
  • Establishing action limits and thresholds for risk monitoring.
  • Utilizing continuous, real-time data analysis for early warning.

Main Results:

  • Action limits effectively detect potential risks early in clinical trials.
  • Breaches in action limits serve as early warnings for compromised trial quality.
  • Understanding QTL parameters and thresholds is key to effective risk management.

Conclusions:

  • Action limits are essential for proactive quality management in clinical trials.
  • Continuous monitoring and timely response to action limit breaches protect trial integrity.
  • This paper provides practical insights into QTL and action limit application.